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Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR III)

Primary Purpose

Intraventricular Hemorrhage

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Alteplase
Normal saline
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraventricular Hemorrhage focused on measuring intraventricular hemorrhage thrombolysis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-80
  • Symptom onset less than 24 hrs prior to diagnostic CT scan
  • Spontaneous ICH less than or equal to 30 cc or primary IVH
  • IVH obstructing 3rd and/or 4th ventricles
  • ICH clot stability at 6 hours or more post IVC placement
  • IVH clot stability at 6 hours or more post IVC placement
  • Catheter tract bleeding stability 6 hours or more post IVC placement
  • EVD placed per standard medical care
  • SBP less than 200 mmHg sustained for 6 hours prior to drug administration
  • Able to randomize within 72 hours of diagnostic CT scan
  • Historical Rankin of 0 or 1

Exclusion Criteria:

  • Suspected or untreated ruptured cerebral aneurysm, AVM, or tumor
  • Presence of a choroid plexus vascular malformation or Moyamoya
  • Clotting disorders
  • Platelet count less than 100,000, INR greater than 1.4
  • Pregnancy
  • Infratentorial hemorrhage
  • SAH at clinical presentation
  • ICH/IVH enlargement that cannot be stabilized in the treatment time window
  • Ongoing internal bleeding
  • Superficial or surface bleeding
  • Prior enrollment in the study
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
  • Planned or simultaneous participation (between screening and Day-30) in another interventional medical investigation or clinical trial.
  • No subject or legal representative to give written informed consent

Sites / Locations

  • University of Alabama at Birmingham
  • Mayo Clinic, Arizona
  • Cedars-Sinai Medical Center
  • University of Southern California - Keck School of Medicine
  • University of California Los Angeles
  • Stanford University
  • Hartford Hospital
  • Yale University
  • Georgetown University
  • Mayo Clinic, Jacksonville
  • Intercoastal Medical Center
  • University of South Florida
  • Rush University
  • University of Illinois at Chicago
  • University of Chicago
  • Ruan Neurology Clinical and Research Center
  • University of Iowa
  • Kansas University Medical Center
  • University of Maryland
  • Johns Hopkins University
  • Henry Ford Health System
  • St. Luke's Brain and Stroke Institute
  • St. Louis University
  • Springfield Neurological and Spine Institute
  • Cooper University Hospital
  • New Jersey Neuroscience Institute at JFK
  • University of Buffalo
  • Northshore University Hospital Long Island
  • Mount Sinai Hospital
  • Columbia University
  • SUNY Upstate Medical Center
  • Wake Forest University
  • University of Cincinnati
  • Case-Western Reserve University Hospital
  • Ohio State University Medical Center
  • Maine Medical Center
  • Providence Stroke Center
  • Abington Memorial Hospital
  • Penn State Hershey Medical Center
  • Thomas Jefferson University Hospital
  • Temple University Hospital
  • Albert Einstein Medical Center
  • Allegheny General Hospital
  • University of Pittsburgh Medical Center
  • Medical University of South Carolina
  • Vanderbilt
  • University of Texas, Southwestern, Dallas
  • University of Texas, Houston
  • University of Texas, San Antonio
  • University of Utah
  • Virginia Commonwealth University
  • Medical College of Wisconsin
  • Hospital Sao Jose, Joinville
  • Hospital de Clinicas de Porto Alegre
  • Hospital de Pronto Socorro de Porto Alegre
  • Hospital de Clinicas de Ribeirao Preto
  • Hospital Sao Paulo Universidade Federal de Sao Paulo / UNIFESP
  • University of Alberta
  • Montreal Neurological Institute at McGill University
  • University of Erlangen
  • University of Halle
  • University of Heidelberg
  • University of Leipzig
  • University of Mainz
  • University of Tubingen
  • University of Szeged
  • Honved Korhaz
  • University of Debrecen
  • University of Pecs
  • Rambam Medical Center
  • Hadassah Hebrew University Hospital
  • Chaim Sheba Medical Center
  • Sourasky Medical Center
  • Bellvitge Hospital
  • Hospital de la Santa Creu i Sant Pau
  • Vall d'Hebron University Hospital
  • University of Zurich
  • University Hospital, Inselpital, Bern
  • Salford Royal NHS Foundation Trust
  • Newcastle General Hospital
  • University of Southampton Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Alteplase

Saline Placebo

Arm Description

administration of alteplase via the intraventricular catheter

1 ml of normal saline administered via the intraventricular catheter

Outcomes

Primary Outcome Measures

Participants With Modified Rankin Scale (mRS) <=3 - Dichotomized Analysis
Analysis modified on September 29, 2015 to account for adaptive randomization. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Participant Score on the Modified Rankin Scale (mRS) - Ordinal Analysis
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Participants With Modified Rankin Scale (mRS) <=4 - Dichotomized Analysis
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Random Effects Assessment of Site Effect on Modified Rankin Scale (mRS) <= 3
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Longitudinal Assessment of Participants With Modified Rankin Scale (mRS) <=3
Comparing longitudinal modified Rankin Scale (mRS) scores 0-3 at Day 30 and Day 180. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).

Secondary Outcome Measures

All Cause Mortality
Clot Removal (Amount of Residual Blood)
Change in blood volume measured between stability scan and end of treatment scan
Intensity of Critical Care Management - Hospital Days
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Intensity of Critical Care Management - ICU Days
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Intensity of Critical Care Management - ICP Management
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Intensity of Critical Care Management - Mechanical Ventilation
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Intensity of Critical Care Management - Pressors
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Intensity of Critical Care Management - Shunts
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Intensity of Critical Care Management - All Infections
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Intensity of Critical Care Management - Pneumonia
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Intensity of Critical Care Management - All Infections
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Safety/Mortality - Mortality Within 30 Days
Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.
Safety/Mortality - Bacterial Brain Infections Within 30 Days
Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.
Safety/Mortality - Systematic Bleeds Within 72 Hours
Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.
Safety/Mortality - Systematic Bleeds Within 30 Days
Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.
Adverse and Serious Adverse Events
Assessment of number of adverse and serious adverse events by treatment group.
Predicting Hazards of Death by Treatment Group
Cox Proportional Hazards Model is used to predict the hazards ratio by treatment group.
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (African-American)
Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (White)
Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Female)
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Male)
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (65 Years or Under)
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (Over 65 Years)
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Less Than 20ml)
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (20-50ml)
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Greater Than 50ml)
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Thalamic)
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Non-Thalamic)
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Functional Status - Barthel Index
Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The Barthel Index (BI) assesses ten functional tasks of daily living, and each task provides a measure for level of independence. Scores range from 0 and 100, with a higher score indicating greater independence.
Functional Status - Participants With Extended Glasgow Outcome (eGOS) Score >=Upper Severe Disability
Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The extended Glasgow Outcome Scale (eGOS) is a global scale for functional outcome with eight categories: 1 - Death, 2 - Vegetative State, 3 - Lower Severe Disability, 4 - Upper Severe Disability, 5 - Lower Moderate Disability, 6 - Upper Moderate Disability, 7 - Lower Good Recovery, 8 - Upper Good Recovery.
Functional Status - National Institutes of Health Stroke Scale (NIHSS)
Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The National Institutes of Health Stroke Scale (NIHSS) is a 15-item scale that assesses language, motor function, sensory loss, consciousness, visual fields, extraocular movements, coordination, neglect, and speech. It is scored from 0 (no stroke symptoms) to 42 (severe stroke).
Quality of Life - Stroke Impact Scale (SIS) - Strength
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
Quality of Life - Stroke Impact Scale (SIS) - Mobility
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
Quality of Life - Stroke Impact Scale (SIS) - Hand Function
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
Quality of Life - Stroke Impact Scale (SIS) - Activities of Daily Living
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
Quality of Life - Stroke Impact Scale (SIS) - Communication
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
Quality of Life - Stroke Impact Scale (SIS) - Thinking
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
Quality of Life - Stroke Impact Scale (SIS) - Emotion
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
Quality of Life - Stroke Impact Scale (SIS) - Participation
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
Quality of Life - Stroke Impact Scale (SIS) - Recovery
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
Quality of Life - EuroQol Visual Analogue Scale (EQ-VAS)
Assessment of SIS and EuroQol Visual Analog Scale by group. EuroQol Visual Analogue Scale (EQ-VAS) is a self-reported measure of health status. It is a marked scale where individuals draw a line to indicate their health, with end points of 0 (the worst health you can imagine) and 100 (the best health you can imagine).

Full Information

First Posted
October 31, 2008
Last Updated
November 9, 2018
Sponsor
Johns Hopkins University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Genentech, Inc., Emissary International LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00784134
Brief Title
Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III
Acronym
CLEAR III
Official Title
Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Genentech, Inc., Emissary International LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The overall objective of this Phase III clinical trial is to obtain information from a population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of current clinical practice and national demographics of ICH regarding the benefit (or lack thereof) of IVH clot removal on subject function as measured by modified Rankin Scale (mRS). This application requests funding for five years to initiate a Phase III randomized clinical trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage. The investigators propose to compare extraventricular drainage (EVD) use plus recombinant tissue plasminogen activator (rt-PA; Alteplase; Genentech, Inc., San Francisco, CA) with EVD+ placebo in the management and treatment of subjects with small intracerebral hemorrhage (ICH) and large intraventricular hemorrhage (IVH defined as ICH < 30 cc and obstruction of the 3rd or 4th ventricles by intraventricular blood clot).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraventricular Hemorrhage
Keywords
intraventricular hemorrhage thrombolysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alteplase
Arm Type
Experimental
Arm Description
administration of alteplase via the intraventricular catheter
Arm Title
Saline Placebo
Arm Type
Placebo Comparator
Arm Description
1 ml of normal saline administered via the intraventricular catheter
Intervention Type
Drug
Intervention Name(s)
Alteplase
Other Intervention Name(s)
Cathflo Activase, rt-PA
Intervention Description
1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses
Intervention Type
Other
Intervention Name(s)
Normal saline
Intervention Description
1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses
Primary Outcome Measure Information:
Title
Participants With Modified Rankin Scale (mRS) <=3 - Dichotomized Analysis
Description
Analysis modified on September 29, 2015 to account for adaptive randomization. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Time Frame
180 days
Title
Participant Score on the Modified Rankin Scale (mRS) - Ordinal Analysis
Description
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Time Frame
180 days
Title
Participants With Modified Rankin Scale (mRS) <=4 - Dichotomized Analysis
Description
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Time Frame
180 days
Title
Random Effects Assessment of Site Effect on Modified Rankin Scale (mRS) <= 3
Description
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Time Frame
180 days
Title
Longitudinal Assessment of Participants With Modified Rankin Scale (mRS) <=3
Description
Comparing longitudinal modified Rankin Scale (mRS) scores 0-3 at Day 30 and Day 180. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Time Frame
30 days and 180 days
Secondary Outcome Measure Information:
Title
All Cause Mortality
Time Frame
180 days
Title
Clot Removal (Amount of Residual Blood)
Description
Change in blood volume measured between stability scan and end of treatment scan
Time Frame
72 hours
Title
Intensity of Critical Care Management - Hospital Days
Description
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Time Frame
30 days
Title
Intensity of Critical Care Management - ICU Days
Description
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Time Frame
30 days
Title
Intensity of Critical Care Management - ICP Management
Description
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Time Frame
30 days
Title
Intensity of Critical Care Management - Mechanical Ventilation
Description
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Time Frame
30 days
Title
Intensity of Critical Care Management - Pressors
Description
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Time Frame
30 days
Title
Intensity of Critical Care Management - Shunts
Description
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Time Frame
30 days
Title
Intensity of Critical Care Management - All Infections
Description
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Time Frame
30 days
Title
Intensity of Critical Care Management - Pneumonia
Description
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Time Frame
30 days
Title
Intensity of Critical Care Management - All Infections
Description
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Time Frame
180 days
Title
Safety/Mortality - Mortality Within 30 Days
Description
Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.
Time Frame
30 days
Title
Safety/Mortality - Bacterial Brain Infections Within 30 Days
Description
Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.
Time Frame
30 days
Title
Safety/Mortality - Systematic Bleeds Within 72 Hours
Description
Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.
Time Frame
72 hours
Title
Safety/Mortality - Systematic Bleeds Within 30 Days
Description
Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.
Time Frame
30 days
Title
Adverse and Serious Adverse Events
Description
Assessment of number of adverse and serious adverse events by treatment group.
Time Frame
180 days
Title
Predicting Hazards of Death by Treatment Group
Description
Cox Proportional Hazards Model is used to predict the hazards ratio by treatment group.
Time Frame
180 days
Title
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (African-American)
Description
Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Time Frame
180 days
Title
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (White)
Description
Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Time Frame
180 days
Title
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Female)
Description
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Time Frame
180 days
Title
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Male)
Description
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Time Frame
180 days
Title
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (65 Years or Under)
Description
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Time Frame
180 days
Title
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (Over 65 Years)
Description
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Time Frame
180 days
Title
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Less Than 20ml)
Description
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Time Frame
180 days
Title
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (20-50ml)
Description
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Time Frame
180 days
Title
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Greater Than 50ml)
Description
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Time Frame
180 days
Title
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Thalamic)
Description
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Time Frame
180 days
Title
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Non-Thalamic)
Description
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Time Frame
180 days
Title
Functional Status - Barthel Index
Description
Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The Barthel Index (BI) assesses ten functional tasks of daily living, and each task provides a measure for level of independence. Scores range from 0 and 100, with a higher score indicating greater independence.
Time Frame
180 days
Title
Functional Status - Participants With Extended Glasgow Outcome (eGOS) Score >=Upper Severe Disability
Description
Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The extended Glasgow Outcome Scale (eGOS) is a global scale for functional outcome with eight categories: 1 - Death, 2 - Vegetative State, 3 - Lower Severe Disability, 4 - Upper Severe Disability, 5 - Lower Moderate Disability, 6 - Upper Moderate Disability, 7 - Lower Good Recovery, 8 - Upper Good Recovery.
Time Frame
180 days
Title
Functional Status - National Institutes of Health Stroke Scale (NIHSS)
Description
Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The National Institutes of Health Stroke Scale (NIHSS) is a 15-item scale that assesses language, motor function, sensory loss, consciousness, visual fields, extraocular movements, coordination, neglect, and speech. It is scored from 0 (no stroke symptoms) to 42 (severe stroke).
Time Frame
180 days
Title
Quality of Life - Stroke Impact Scale (SIS) - Strength
Description
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
Time Frame
180 days
Title
Quality of Life - Stroke Impact Scale (SIS) - Mobility
Description
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
Time Frame
180 days
Title
Quality of Life - Stroke Impact Scale (SIS) - Hand Function
Description
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
Time Frame
180 days
Title
Quality of Life - Stroke Impact Scale (SIS) - Activities of Daily Living
Description
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
Time Frame
180 days
Title
Quality of Life - Stroke Impact Scale (SIS) - Communication
Description
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
Time Frame
180 days
Title
Quality of Life - Stroke Impact Scale (SIS) - Thinking
Description
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
Time Frame
180 days
Title
Quality of Life - Stroke Impact Scale (SIS) - Emotion
Description
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
Time Frame
180 days
Title
Quality of Life - Stroke Impact Scale (SIS) - Participation
Description
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
Time Frame
180 days
Title
Quality of Life - Stroke Impact Scale (SIS) - Recovery
Description
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
Time Frame
180 days
Title
Quality of Life - EuroQol Visual Analogue Scale (EQ-VAS)
Description
Assessment of SIS and EuroQol Visual Analog Scale by group. EuroQol Visual Analogue Scale (EQ-VAS) is a self-reported measure of health status. It is a marked scale where individuals draw a line to indicate their health, with end points of 0 (the worst health you can imagine) and 100 (the best health you can imagine).
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-80 Symptom onset less than 24 hrs prior to diagnostic CT scan Spontaneous ICH less than or equal to 30 cc or primary IVH IVH obstructing 3rd and/or 4th ventricles ICH clot stability at 6 hours or more post IVC placement IVH clot stability at 6 hours or more post IVC placement Catheter tract bleeding stability 6 hours or more post IVC placement EVD placed per standard medical care SBP less than 200 mmHg sustained for 6 hours prior to drug administration Able to randomize within 72 hours of diagnostic CT scan Historical Rankin of 0 or 1 Exclusion Criteria: Suspected or untreated ruptured cerebral aneurysm, AVM, or tumor Presence of a choroid plexus vascular malformation or Moyamoya Clotting disorders Platelet count less than 100,000, INR greater than 1.4 Pregnancy Infratentorial hemorrhage SAH at clinical presentation ICH/IVH enlargement that cannot be stabilized in the treatment time window Ongoing internal bleeding Superficial or surface bleeding Prior enrollment in the study Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated Planned or simultaneous participation (between screening and Day-30) in another interventional medical investigation or clinical trial. No subject or legal representative to give written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel F. Hanley, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Mayo Clinic, Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of Southern California - Keck School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94034
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8018
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Mayo Clinic, Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Intercoastal Medical Center
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Rush University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Ruan Neurology Clinical and Research Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21230
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
St. Luke's Brain and Stroke Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
St. Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Springfield Neurological and Spine Institute
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
New Jersey Neuroscience Institute at JFK
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08818
Country
United States
Facility Name
University of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Northshore University Hospital Long Island
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
SUNY Upstate Medical Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Case-Western Reserve University Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
04102
Country
United States
Facility Name
Providence Stroke Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas, Southwestern, Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Texas, Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas, San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Hospital Sao Jose, Joinville
City
Joinville
State/Province
Santa Catarina
ZIP/Postal Code
89202165
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Hospital de Pronto Socorro de Porto Alegre
City
Porto Alegre
Country
Brazil
Facility Name
Hospital de Clinicas de Ribeirao Preto
City
Ribeirão Preto
ZIP/Postal Code
14015-130
Country
Brazil
Facility Name
Hospital Sao Paulo Universidade Federal de Sao Paulo / UNIFESP
City
Sao Paulo
ZIP/Postal Code
04039032
Country
Brazil
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Montreal Neurological Institute at McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
University of Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
University of Halle
City
Halle
ZIP/Postal Code
D-06120
Country
Germany
Facility Name
University of Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
University of Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
University of Mainz
City
Mainz
ZIP/Postal Code
D-55131
Country
Germany
Facility Name
University of Tubingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
University of Szeged
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Honved Korhaz
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
University of Debrecen
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
University of Pecs
City
Pecs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah Hebrew University Hospital
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat-Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Bellvitge Hospital
City
Barcelona
ZIP/Postal Code
08015
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Vall d'Hebron University Hospital
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
University of Zurich
City
Zurich
State/Province
ZH
ZIP/Postal Code
CH-8091
Country
Switzerland
Facility Name
University Hospital, Inselpital, Bern
City
Bern
Country
Switzerland
Facility Name
Salford Royal NHS Foundation Trust
City
Salford
State/Province
Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Newcastle General Hospital
City
Newcastle upon Tyne
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
University of Southampton Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35086362
Citation
Roh DJ, Asonye IS, Carvalho Poyraz F, Magid-Bernstein JR, Joiner EF, Avadhani R, Awad I, Hanley DF, Ziai WC, Murthy SB. Intraventricular Hemorrhage Expansion in the CLEAR III Trial: A Post Hoc Exploratory Analysis. Stroke. 2022 Jun;53(6):1847-1853. doi: 10.1161/STROKEAHA.121.037438. Epub 2022 Jan 28.
Results Reference
derived
PubMed Identifier
32026447
Citation
Hansen BM, Ullman N, Muschelli J, Norrving B, Dlugash R, Avadhani R, Awad I, Zuccarello M, Ziai WC, Hanley DF, Thompson RE, Lindgren A; MISTIE and CLEAR Investigators. Relationship of White Matter Lesions with Intracerebral Hemorrhage Expansion and Functional Outcome: MISTIE II and CLEAR III. Neurocrit Care. 2020 Oct;33(2):516-524. doi: 10.1007/s12028-020-00916-4.
Results Reference
derived
PubMed Identifier
31571176
Citation
Porter AL, Ebot J, Lane K, Mooney LH, Lannen AM, Richie EM, Dlugash R, Mayo S, Brott TG, Ziai W, Freeman WD, Hanley DF. Enhancing the Informed Consent Process Using Shared Decision Making and Consent Refusal Data from the CLEAR III Trial. Neurocrit Care. 2020 Feb;32(1):340-347. doi: 10.1007/s12028-019-00860-y.
Results Reference
derived
PubMed Identifier
31177984
Citation
Eslami V, Tahsili-Fahadan P, Rivera-Lara L, Gandhi D, Ali H, Parry-Jones A, Nelson LS, Thompson RE, Nekoobakht-Tak S, Dlugash R, McBee N, Awad I, Hanley DF, Ziai WC. Influence of Intracerebral Hemorrhage Location on Outcomes in Patients With Severe Intraventricular Hemorrhage. Stroke. 2019 Jul;50(7):1688-1695. doi: 10.1161/STROKEAHA.118.024187. Epub 2019 Jun 10.
Results Reference
derived
PubMed Identifier
28887375
Citation
Fam MD, Zeineddine HA, Eliyas JK, Stadnik A, Jesselson M, McBee N, Lane K, Cao Y, Wu M, Zhang L, Thompson RE, John S, Ziai W, Hanley DF, Awad IA; CLEAR III Trial Investigators. CSF inflammatory response after intraventricular hemorrhage. Neurology. 2017 Oct 10;89(15):1553-1560. doi: 10.1212/WNL.0000000000004493. Epub 2017 Sep 8.
Results Reference
derived
PubMed Identifier
28081952
Citation
Hanley DF, Lane K, McBee N, Ziai W, Tuhrim S, Lees KR, Dawson J, Gandhi D, Ullman N, Mould WA, Mayo SW, Mendelow AD, Gregson B, Butcher K, Vespa P, Wright DW, Kase CS, Carhuapoma JR, Keyl PM, Diener-West M, Muschelli J, Betz JF, Thompson CB, Sugar EA, Yenokyan G, Janis S, John S, Harnof S, Lopez GA, Aldrich EF, Harrigan MR, Ansari S, Jallo J, Caron JL, LeDoux D, Adeoye O, Zuccarello M, Adams HP Jr, Rosenblum M, Thompson RE, Awad IA; CLEAR III Investigators. Thrombolytic removal of intraventricular haemorrhage in treatment of severe stroke: results of the randomised, multicentre, multiregion, placebo-controlled CLEAR III trial. Lancet. 2017 Feb 11;389(10069):603-611. doi: 10.1016/S0140-6736(16)32410-2. Epub 2017 Jan 10.
Results Reference
derived
PubMed Identifier
26243227
Citation
Webb AJ, Ullman NL, Morgan TC, Muschelli J, Kornbluth J, Awad IA, Mayo S, Rosenblum M, Ziai W, Zuccarrello M, Aldrich F, John S, Harnof S, Lopez G, Broaddus WC, Wijman C, Vespa P, Bullock R, Haines SJ, Cruz-Flores S, Tuhrim S, Hill MD, Narayan R, Hanley DF; MISTIE and CLEAR Investigators. Accuracy of the ABC/2 Score for Intracerebral Hemorrhage: Systematic Review and Analysis of MISTIE, CLEAR-IVH, and CLEAR III. Stroke. 2015 Sep;46(9):2470-6. doi: 10.1161/STROKEAHA.114.007343. Epub 2015 Aug 4.
Results Reference
derived
Links:
URL
http://braininjuryoutcomes.com
Description
Related Info
Available IPD and Supporting Information:
Available IPD/Information Type
Data repository-VISTA
Available IPD/Information URL
http://vista.gla.ac.uk
Available IPD/Information Identifier
Data repository-VISTA
Available IPD/Information Comments
when available
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://vista.gla.ac.uk
Available IPD/Information Comments
when available
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
http://vista.gla.ac.uk
Available IPD/Information Comments
when available

Learn more about this trial

Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III

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