Reperfusion With Cooling in Cerebral Acute Ischemia

Stroke, Acute Clinical Trial

— ReCCLAIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01585597
• Other study ID #: IRB00056889
• Secondary ID: MSNC 01
• Status: Completed
• Phase: Phase 1
• First received: April 22, 2012
• Last updated: July 7, 2014
• Start date: May 2012
• Est. completion date: August 2012

Study information

• Verified date: July 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke, Acute

Intervention

Device:
• Zoll- Coolgaurd 3000
Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour.

Locations

Country	Name	City	State
United States	Marcus Stroke and Neuroscience Center at Grady Memorial Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 Hours	Yes
Secondary	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	90 days post hospitalization	No