Reperfusion With Cooling in Cerebral Acute Ischemia II

Withdrawn before enrolling · Not applicable

Conditions studied: Ischemic Stroke, Hypothermia

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).This will be achieved by comparing patients that have undergone hypothermia to those that have not.

Key facts

Study ID: NCT01728649
Run by: WellStar Health System
People needed: 0
Starts: 2013-02-01
Expected to finish: 2015-06-01
Last updated by the study team: 2018-09-13

Who can join

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

You may qualify if…

Male or female subjects of any ethnicity and age >/=18 but </= 85 years;
Symptom onset </=8 hours;
Symptoms consistent with an ischemic stroke with a large vessel occlusion (Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA) terminus) as determined by vascular imaging, CT or MRI;
Alberta Stroke Program Early CT Score (ASPECTS) of 5-10 on non-contrast CT of the brain;
Ability to undergo endovascular reperfusion therapy;
No contraindications to general anesthesia or allergies to any components associated with the anticipated diagnostic or treatment procedures that cannot be treated;
A pre-treatment modified Rankin Scale (mRS) of 0 or 1;
Arterial puncture performed under 8 hours from symptom onset or last seen normal
Baseline MRI or CT scan shows no hemorrhage;
National Institutes of Health Stroke Scale (NIHSS) 14-29;
Subject has either 1) failed iv tissue plasminogen activator (tPA) therapy or 2) contradicted for iv tPA therapy;
Subject is capable of complying with study procedures and agrees to complete all required study procedures, study visits and associated activities.
Subject must be able to understand and give written informed consent.

You may not qualify if…

Females of childbearing potential who are pregnant or not using adequate contraception;
Bleeding diathesis with a platelet count < 50,000 or International Normalized Ratio (INR) >1.5 or any active or recent (within 10 to 30 days) hemorrhage;
History of genetically confirmed hypercoagulable syndrome;
Any condition that excludes MRI imaging;
History of dementia, currently on Aricept or Namenda, or other Alzheimer's like symptoms;
End stage renal disease on hemodialysis;
History of cardiac arrest;
Presence of an inferior vena cava (IVC) filter;
Contrast dye allergy with history of anaphylaxis, known serious sensitivity to contrast agents or any condition in which angiography is contraindicated;
Known allergy to meperidine or buspar;
Sustained hypertension (systolic blood pressure (SBP) > 185 or diastolic blood pressure (DBP) > 110 refractory to treatment);
Baseline CT/MRI of head showing evidence of mass effect with mid-line shift, hemorrhage, intracranial tumor, arterial vasculitis or dissection, or bilateral stroke;
Presence of any other serious comorbidity that would be likely to impact life expectancy to less than 6 months or limit subject cooperation or study compliance;
Concurrent participation in an investigational clinical study that has not completed the follow-up period or planned participation in another study within the next 3 months;
Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete, good quality data or the completion of the research study

Where it is running

Grady Memorial Hospital — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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