Phase 1 N=20 Treatment

Reperfusion With Cooling in Cerebral Acute Ischemia

Stroke, Acute

Bottom Line

View on ClinicalTrials.gov: NCT01585597 ↗

Enrolled (actual)

Serious AEs

40.0%

Results posted

Aug 2014

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

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Zoll- Coolgaurd 3000 (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Emory University
Primary completion: Aug 2012

Outcome Measures

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

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).

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.