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Reperfusion With Cooling in Cerebral Acute Ischemia (ReCCLAIM)

Primary Purpose

Stroke, Acute

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Zoll- Coolgaurd 3000

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring Ischemic Stoke, Endovascular Reperfusion, Reperfusion Injury, Mild hypothermia

Eligibility Criteria

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

Inclusion Criteria:

Age 18-85 years old
Symptoms consistent with an ischemic stroke with a large vessel occlusion (MCA, ICA-terminus) as determined by vascular imaging
ASPECTS score of 5-7 on non-contrast CT of the brain
Ability to undergo endovascular reperfusion therapy
Must have no contraindications to general anesthesia
A pre-treatment modified Rankin Score of 0 or 1
Arterial puncture performed under 8 hours from symptom onset or last seen normal
Immediate post reperfusion CT scan shows no hemorrhage

Exclusion Criteria:

Bleeding diathesis with a platelet count < 50,000 or INR > 1.5
Involved in another clinical trial
History of dementia
End stage renal disease on hemodialysis
History of ventricular dysrhythmias
Life threatening medical condition precluding survival under 6 months
Presence of an IVC filter
Contrast dye allergy with history of anaphylaxis

Sites / Locations

Marcus Stroke and Neuroscience Center at Grady Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mild Hypothermia

Arm Description

Reduction of body temperature to 34 degrees centigrade. This will be accomplished using the Zoll Coolguard .

Outcomes

Primary Outcome Measures

Number of Participants With Reperfusion Injury \ Hemorrhagic Transformation

Asymptomatic and symptomatic Hemorrhages defined as homogenous density occupying >30% of the infarct zone with mass effect

Secondary Outcome Measures

Modified Rankin Scale 0-2

Modified Rankin Score 0=no symptoms no significant disability slight disability needs help moderate disability moderate serve disability severe disability 0-2 = good outcome 3-5= poor outcome

Full Information

NCT ID

NCT01585597

First Posted

April 22, 2012

Last Updated

July 7, 2014

Sponsor

Emory University

1. Study Identification

Unique Protocol Identification Number

NCT01585597

Brief Title

Reperfusion With Cooling in Cerebral Acute Ischemia

Acronym

ReCCLAIM

Official Title

Phase 1 Study of Mild Induced Hypothermia After Endovascular Revascularization in Acute Ischemic Stroke of the Anterior Circulation

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

4. Oversight

Data Monitoring Committee

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).

6. Conditions and Keywords

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

Stroke, Acute

Keywords

Ischemic Stoke, Endovascular Reperfusion, Reperfusion Injury, Mild hypothermia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mild Hypothermia

Arm Type

Experimental

Arm Description

Reduction of body temperature to 34 degrees centigrade. This will be accomplished using the Zoll Coolguard .

Intervention Type

Device

Intervention Name(s)

Zoll- Coolgaurd 3000

Intervention Description

Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour.

Primary Outcome Measure Information:

Title

Number of Participants With Reperfusion Injury \ Hemorrhagic Transformation

Description

Asymptomatic and symptomatic Hemorrhages defined as homogenous density occupying >30% of the infarct zone with mass effect

Time Frame

24 Hours

Secondary Outcome Measure Information:

Title

Modified Rankin Scale 0-2

Description

Modified Rankin Score 0=no symptoms no significant disability slight disability needs help moderate disability moderate serve disability severe disability 0-2 = good outcome 3-5= poor outcome

Time Frame

90 days post hospitalization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-85 years old Symptoms consistent with an ischemic stroke with a large vessel occlusion (MCA, ICA-terminus) as determined by vascular imaging ASPECTS score of 5-7 on non-contrast CT of the brain Ability to undergo endovascular reperfusion therapy Must have no contraindications to general anesthesia A pre-treatment modified Rankin Score of 0 or 1 Arterial puncture performed under 8 hours from symptom onset or last seen normal Immediate post reperfusion CT scan shows no hemorrhage Exclusion Criteria: Bleeding diathesis with a platelet count < 50,000 or INR > 1.5 Involved in another clinical trial History of dementia End stage renal disease on hemodialysis History of ventricular dysrhythmias Life threatening medical condition precluding survival under 6 months Presence of an IVC filter Contrast dye allergy with history of anaphylaxis

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rishi Gupta, MD

Organizational Affiliation

Emory University

Official's Role

Study Director

Facility Information:

Facility Name

Marcus Stroke and Neuroscience Center at Grady Memorial Hospital

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30303

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23468538

Citation

Horn CM, Sun CH, Nogueira RG, Patel VN, Krishnan A, Glenn BA, Belagaje SR, Thomas TT, Anderson AM, Frankel MR, Schindler KM, Gupta R. Endovascular Reperfusion and Cooling in Cerebral Acute Ischemia (ReCCLAIM I). J Neurointerv Surg. 2014 Mar;6(2):91-5. doi: 10.1136/neurintsurg-2013-010656. Epub 2013 Mar 6.

Results Reference

derived

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Reperfusion With Cooling in Cerebral Acute Ischemia

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