Reperfusion With Cooling in Cerebral Acute Ischemia

Phase 1

Completed

• Conditions: Stroke, Acute
• Interventions: Device: Zoll- Coolgaurd 3000

• Registration Number: NCT01585597
• Lead Sponsor: Emory University

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-04-22
• Study First Submitted QC: 2012-04-24
• Study First Posted: 2012-04-26
• Study Start: 2012-05
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Results First Submitted: 2014-01-07
• Status Verified: 2014-07
• Results First Submitted QC: 2014-07-07
• Last Update Submitted: 2014-07-07
• Results First Posted: 2014-08-01
• Last Update Posted: 2014-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mild Hypothermia	Zoll- Coolgaurd 3000	Reduction of body temperature to 34 degrees centigrade. This will be accomplished using the Zoll Coolguard .

Primary Outcome Measures

Name	Time	Method
Number of Participants With Reperfusion Injury \ Hemorrhagic Transformation	24 Hours	Asymptomatic and symptomatic Hemorrhages defined as homogenous density occupying \>30% of the infarct zone with mass effect

Secondary Outcome Measures

Name	Time	Method
Modified Rankin Scale 0-2	90 days post hospitalization	Modified Rankin Score 0=no symptoms; 1. no significant disability; 2. slight disability needs help; 3. moderate disability; 4. moderate serve disability; 5. severe disability 0-2 = good outcome 3-5= poor outcome

Trial Locations

Locations (1)

Marcus Stroke and Neuroscience Center at Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States