Reperfusion With Cooling in Cerebral Acute Ischemia (ReCCLAIM)

Emory University

Status and phase: Completed; Phase 1

Conditions: Stroke, Acute

Treatments: Device: Zoll- Coolgaurd 3000

Study type: Interventional

Funder types: Other

Identifiers

NCT01585597

IRB00056889

MSNC 01 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 20 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Mild Hypothermia

Experimental group

Description:

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

Treatment:

Device: Zoll- Coolgaurd 3000