search
Back to results

Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage (IVH)

Primary Purpose

Intraventricular Hemorrhage

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rt-PA thrombolysis
endoscopic hematoma evacuation
Sponsored by
Albany Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraventricular Hemorrhage

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-75
  • Radiographic evidence of intraventricular hemorrhage with hydrocephalus
  • Admission Glasgow Coma Scale ≥ 5 (motor score ≥ 2)
  • Placement of an external ventricular drain with an opening pressure >20 mm Hg

Exclusion Criteria:

  • Intraventricular hemorrhage secondary to cerebral aneurysm, arteriovenous malformation, or tumor
  • Coagulopathy (Platelet count <100,000, International normalized ratio >1.5. Reversal of warfarin is permitted.)
  • Age <18 or >75
  • Pregnancy (positive pregnancy test)
  • Clotting disorders
  • Medical contraindications to administration of general anesthesia as determined by the attending anesthesiologist
  • Medical contraindications to surgery as determined by the attending neurosurgeon

  • Contraindication to recombinant tissue plasminogen activator administration:

    • Evidence of enlargening intracranial hemorrhage as evidenced by an increase in intracranial hemorrhage volume (>5 ml) on CT obtained after EVD placement
    • Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts
    • Superficial or surface bleeding, observed at vascular puncture and access sites (e.g. venous cutdowns, arterial punctures) or site of recent surgical intervention
  • Evidence of cerebrospinal infection by Gram stain or culture
  • Advanced directive indicating Do Not Resuscitate or Do Not Intubate status

Sites / Locations

  • Albany Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

External Ventricular drainage, Intraventricular Thrombolysis

External Ventricular Drainage and Endoscopic Evacuation

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 5, 2010
Last Updated
June 24, 2011
Sponsor
Albany Medical College
search

1. Study Identification

Unique Protocol Identification Number
NCT01064011
Brief Title
Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage
Acronym
IVH
Official Title
A Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage: External Ventricular Drainage and Intraventricular Thrombolysis vs. External Ventricular Drainage and Endoscopic Evacuation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
January 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Albany Medical College

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Intraventricular hemorrhage comprises about 15% of the 500,000 strokes that occur annually in the United States. In the emergent setting, patients with obstructive hydrocephalus are routinely treated with placement of an external ventricular drain. This study will compare the effect of external ventricular drainage plus intraventricular thrombolysis versus external ventricular drainage plus endoscopic evacuation on neurologic outcomes for patients with hydrocephalus from intraventricular hemorrhage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraventricular Hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
External Ventricular drainage, Intraventricular Thrombolysis
Arm Type
Other
Arm Title
External Ventricular Drainage and Endoscopic Evacuation
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Rt-PA thrombolysis
Intervention Description
patients will be administered a total of six doses of rt-PA (each 1 mg/ml) through the external ventricular drain every eight hours.
Intervention Type
Procedure
Intervention Name(s)
endoscopic hematoma evacuation
Intervention Description
In the operating room under general anesthesia, the external ventricular drain will be removed and the burr hole enlarged to allow for entry of the endoscope. The neuroscope will be introduced through the burr hole down the prior external ventricular drain tract into the ipsilateral ventricle. utilizing a standard technique combining gentle aspiration, continuous irrigation, and grasping forceps,the intraventricular hematoma will be evacuated. After the evacuation the endoscope will be removed and an external ventricular drain will be reattached to a closed system and permitted to drain post-operatively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-75 Radiographic evidence of intraventricular hemorrhage with hydrocephalus Admission Glasgow Coma Scale ≥ 5 (motor score ≥ 2) Placement of an external ventricular drain with an opening pressure >20 mm Hg Exclusion Criteria: Intraventricular hemorrhage secondary to cerebral aneurysm, arteriovenous malformation, or tumor Coagulopathy (Platelet count <100,000, International normalized ratio >1.5. Reversal of warfarin is permitted.) Age <18 or >75 Pregnancy (positive pregnancy test) Clotting disorders Medical contraindications to administration of general anesthesia as determined by the attending anesthesiologist Medical contraindications to surgery as determined by the attending neurosurgeon Contraindication to recombinant tissue plasminogen activator administration: Evidence of enlargening intracranial hemorrhage as evidenced by an increase in intracranial hemorrhage volume (>5 ml) on CT obtained after EVD placement Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts Superficial or surface bleeding, observed at vascular puncture and access sites (e.g. venous cutdowns, arterial punctures) or site of recent surgical intervention Evidence of cerebrospinal infection by Gram stain or culture Advanced directive indicating Do Not Resuscitate or Do Not Intubate status
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Hung Kuo, MD
Phone
518 262-5088
Email
kuoy@mail.amc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tyler Kenning, MD
Phone
518 262-5088
Email
kennint@mail.amc.edu
Facility Information:
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-Hung Kuo, MD
Phone
518-262-5088
Email
kuo@mail.amc.edu
First Name & Middle Initial & Last Name & Degree
Tyler Kenning, MD
Phone
518 262-5088
Email
kennint@mail.amc.edu

12. IPD Sharing Statement

Learn more about this trial

Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage

We'll reach out to this number within 24 hrs