Reperfusion With Cooling in Cerebral Acute Ischemia

Completed · Phase 1

Conditions studied: Stroke, Acute

In brief

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).

Key facts

Study ID: NCT01585597
Run by: Emory University
People needed: 20
Starts: 2012-05-01
Expected to finish: 2012-08-01
Last updated by the study team: 2014-08-01

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Marcus Stroke and Neuroscience Center at Grady Memorial Hospital — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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