Phase 1 Completed N=20 Treatment

Reperfusion With Cooling in Cerebral Acute Ischemia

Stroke, Acute

Source: ClinicalTrials.gov NCT01585597 ↗

Enrolled (actual)

Serious AEs

40.0%

Results posted

Aug 2014

Primary outcomePrimary: Number of Participants With Reperfusion Injury Hemorrhagic Transformation — 3 participants

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Reperfusion Injury Hemorrhagic Transformation	—	—
SECONDARY Modified Rankin Scale 0-2	20	—

Eligibility Criteria

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01585597). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.