search
Back to results

Reperfusion With Cooling in Cerebral Acute Ischemia II (ReCCLAIM II)

Primary Purpose

Ischemic Stroke, Hypothermia

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mild Hypothermia
Sponsored by
WellStar Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Acute Ischemic Stroke, Mild Hypothermia, Stroke, Hypothermia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female subjects of any ethnicity and age >/=18 but </= 85 years;
  • Symptom onset </=8 hours;
  • Symptoms consistent with an ischemic stroke with a large vessel occlusion (Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA) terminus) as determined by vascular imaging, CT or MRI;
  • Alberta Stroke Program Early CT Score (ASPECTS) of 5-10 on non-contrast CT of the brain;
  • Ability to undergo endovascular reperfusion therapy;
  • No contraindications to general anesthesia or allergies to any components associated with the anticipated diagnostic or treatment procedures that cannot be treated;
  • A pre-treatment modified Rankin Scale (mRS) of 0 or 1;
  • Arterial puncture performed under 8 hours from symptom onset or last seen normal
  • Baseline MRI or CT scan shows no hemorrhage;
  • National Institutes of Health Stroke Scale (NIHSS) 14-29;
  • Subject has either 1) failed iv tissue plasminogen activator (tPA) therapy or 2) contradicted for iv tPA therapy;
  • Subject is capable of complying with study procedures and agrees to complete all required study procedures, study visits and associated activities.
  • Subject must be able to understand and give written informed consent.

Exclusion Criteria:

  • Females of childbearing potential who are pregnant or not using adequate contraception;
  • Bleeding diathesis with a platelet count < 50,000 or International Normalized Ratio (INR) >1.5 or any active or recent (within 10 to 30 days) hemorrhage;
  • History of genetically confirmed hypercoagulable syndrome;
  • Any condition that excludes MRI imaging;
  • History of dementia, currently on Aricept or Namenda, or other Alzheimer's like symptoms;
  • End stage renal disease on hemodialysis;
  • History of cardiac arrest;
  • Presence of an inferior vena cava (IVC) filter;
  • Contrast dye allergy with history of anaphylaxis, known serious sensitivity to contrast agents or any condition in which angiography is contraindicated;
  • Known allergy to meperidine or buspar;
  • Sustained hypertension (systolic blood pressure (SBP) > 185 or diastolic blood pressure (DBP) > 110 refractory to treatment);
  • Baseline CT/MRI of head showing evidence of mass effect with mid-line shift, hemorrhage, intracranial tumor, arterial vasculitis or dissection, or bilateral stroke;
  • Presence of any other serious comorbidity that would be likely to impact life expectancy to less than 6 months or limit subject cooperation or study compliance;
  • Concurrent participation in an investigational clinical study that has not completed the follow-up period or planned participation in another study within the next 3 months;
  • Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete, good quality data or the completion of the research study

Sites / Locations

  • Grady Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Normothermia

Mild Hypothermia

Arm Description

As part of standard of care, an interventional reperfusion procedure will be performed on all subjects using current FDA approved devices. After which patient will be started on normothermia attempting to keep core body temp between 38 and 36.5 degrees centigrade. Patients will also undergo blood draws for biomarkers before reperfusion is achieved the immediately, 6 hours then 24 hours after reperfusion.

As part of standard of care, an interventional reperfusion procedure will be performed on all subjects using current FDA cleared device. Patient will also have a Quattro catheter placed in the femoral vein and temperature brought to 33 degrees centigrade as quickly as possible. They will stay in mild hypothermia for 12 hours and then be rewarmed very slowly. Patients will also undergo blood draws for biomarkers before reperfusion is achieved the immediately, 6 hours then 24 hours after reperfusion.

Outcomes

Primary Outcome Measures

Number of participants with adverse events
Evaluation and determination of the following complications pneumonias, central line infections, intra-cerebral hemorrhages, systemic hemorrhages, transient cerebral ischemia, and new strokes.

Secondary Outcome Measures

Hyperintense Acute Reperfusion Marker (HARM)
HARM is a MRI sequence looking at gadolinium enhancement on FLAIR MRI imaging.
Hemorrhagic Conversion
Acute bleeding into the area of the original stroke based on CT or MRI of the head.
National Institutes of Health Stroke Scale (NIHSS)
NIHSS is a scale from 1-42 to evaluate stroke severity
Modified Rankin Scale (mRS)
mRS is a straightforward evaluation of the functional limitations from stroke
Biomarkers
These biomarkers are indicative of ischemia-reperfusion injury

Full Information

First Posted
September 5, 2012
Last Updated
September 11, 2018
Sponsor
WellStar Health System
search

1. Study Identification

Unique Protocol Identification Number
NCT01728649
Brief Title
Reperfusion With Cooling in Cerebral Acute Ischemia II
Acronym
ReCCLAIM II
Official Title
Phase 2 Study of Mild Hypothermia in Combination With Acute Cerebral Vascular Reperfusion in the Setting of Acute Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Withdrawn
Why Stopped
unable to be funded
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
WellStar Health System

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether reducing a patients body temperature (mild hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury (notably reperfusion injury and hemorrhagic conversion) in patients that have suffered a significant interruption of blood flow to an area of brain (occlusion of large proximal cerebral artery) and have undergone successful removal of that interruption (revascularization).This will be achieved by comparing patients that have undergone hypothermia to those that have not.
Detailed Description
This study is designed to examine the safety and proof of concept of therapeutic hypothermia prior to conventional revascularization in subjects experiencing acute ischemic stroke by comparing the results to subjects who remain at normal body temperature (normothermic) and proceed directly to reperfusion via conventional reperfusion intervention. The investigational plan also examines the following outcomes in 85 subjects randomized to either hypothermia or normothermia: Regulation of biomarkers indicative of ischemia-reperfusion injury Changes in blood brain injury using the Hyperintense Acute Reperfusion Marker (HARM) protocol MRI as a surrogate imaging biomarker Incidence of hemorrhagic conversion post reperfusion Neurologic function at 90 days post acute ischemic stroke. The results of this study will be used to power a definitive phase III clinical trial evaluating the combination of hypothermia and revascularization versus reperfusion alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Hypothermia
Keywords
Acute Ischemic Stroke, Mild Hypothermia, Stroke, Hypothermia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normothermia
Arm Type
No Intervention
Arm Description
As part of standard of care, an interventional reperfusion procedure will be performed on all subjects using current FDA approved devices. After which patient will be started on normothermia attempting to keep core body temp between 38 and 36.5 degrees centigrade. Patients will also undergo blood draws for biomarkers before reperfusion is achieved the immediately, 6 hours then 24 hours after reperfusion.
Arm Title
Mild Hypothermia
Arm Type
Experimental
Arm Description
As part of standard of care, an interventional reperfusion procedure will be performed on all subjects using current FDA cleared device. Patient will also have a Quattro catheter placed in the femoral vein and temperature brought to 33 degrees centigrade as quickly as possible. They will stay in mild hypothermia for 12 hours and then be rewarmed very slowly. Patients will also undergo blood draws for biomarkers before reperfusion is achieved the immediately, 6 hours then 24 hours after reperfusion.
Intervention Type
Other
Intervention Name(s)
Mild Hypothermia
Other Intervention Name(s)
Hypothermia, Therapeutic Hypothermia
Intervention Description
Hypothermia will be achieved using the Zoll Thermoguard XP technology with the Quattro catheter. This catheter has a 9.3 Fr diameter and is 4 3cm long. It will be placed in the patients femoral vein via Seldinger technique, before reperfusion is achieved. Hypothermia will be initiated prior to reperfusion. Once temperature has reached 33.5 degrees centigrade the patient will remain at that temperature for 12 hours after which the patient will undergo active gradual rewarming at 0.2 degrees centigrade per hour.
Primary Outcome Measure Information:
Title
Number of participants with adverse events
Description
Evaluation and determination of the following complications pneumonias, central line infections, intra-cerebral hemorrhages, systemic hemorrhages, transient cerebral ischemia, and new strokes.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Hyperintense Acute Reperfusion Marker (HARM)
Description
HARM is a MRI sequence looking at gadolinium enhancement on FLAIR MRI imaging.
Time Frame
48+/- 24 hours
Title
Hemorrhagic Conversion
Description
Acute bleeding into the area of the original stroke based on CT or MRI of the head.
Time Frame
48hrs
Title
National Institutes of Health Stroke Scale (NIHSS)
Description
NIHSS is a scale from 1-42 to evaluate stroke severity
Time Frame
90 days
Title
Modified Rankin Scale (mRS)
Description
mRS is a straightforward evaluation of the functional limitations from stroke
Time Frame
90 days
Title
Biomarkers
Description
These biomarkers are indicative of ischemia-reperfusion injury
Time Frame
Before therapy then immediately after, 8hrs, and 24hrs after reperfusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects of any ethnicity and age >/=18 but </= 85 years; Symptom onset </=8 hours; Symptoms consistent with an ischemic stroke with a large vessel occlusion (Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA) terminus) as determined by vascular imaging, CT or MRI; Alberta Stroke Program Early CT Score (ASPECTS) of 5-10 on non-contrast CT of the brain; Ability to undergo endovascular reperfusion therapy; No contraindications to general anesthesia or allergies to any components associated with the anticipated diagnostic or treatment procedures that cannot be treated; A pre-treatment modified Rankin Scale (mRS) of 0 or 1; Arterial puncture performed under 8 hours from symptom onset or last seen normal Baseline MRI or CT scan shows no hemorrhage; National Institutes of Health Stroke Scale (NIHSS) 14-29; Subject has either 1) failed iv tissue plasminogen activator (tPA) therapy or 2) contradicted for iv tPA therapy; Subject is capable of complying with study procedures and agrees to complete all required study procedures, study visits and associated activities. Subject must be able to understand and give written informed consent. Exclusion Criteria: Females of childbearing potential who are pregnant or not using adequate contraception; Bleeding diathesis with a platelet count < 50,000 or International Normalized Ratio (INR) >1.5 or any active or recent (within 10 to 30 days) hemorrhage; History of genetically confirmed hypercoagulable syndrome; Any condition that excludes MRI imaging; History of dementia, currently on Aricept or Namenda, or other Alzheimer's like symptoms; End stage renal disease on hemodialysis; History of cardiac arrest; Presence of an inferior vena cava (IVC) filter; Contrast dye allergy with history of anaphylaxis, known serious sensitivity to contrast agents or any condition in which angiography is contraindicated; Known allergy to meperidine or buspar; Sustained hypertension (systolic blood pressure (SBP) > 185 or diastolic blood pressure (DBP) > 110 refractory to treatment); Baseline CT/MRI of head showing evidence of mass effect with mid-line shift, hemorrhage, intracranial tumor, arterial vasculitis or dissection, or bilateral stroke; Presence of any other serious comorbidity that would be likely to impact life expectancy to less than 6 months or limit subject cooperation or study compliance; Concurrent participation in an investigational clinical study that has not completed the follow-up period or planned participation in another study within the next 3 months; Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete, good quality data or the completion of the research study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Horn, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rishi Gupta, MD
Organizational Affiliation
Emory University
Official's Role
Study Director
Facility Information:
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Reperfusion With Cooling in Cerebral Acute Ischemia II

We'll reach out to this number within 24 hrs