Status:
COMPLETED
Mild Hypothermia in Acute Ischemic Stroke
Lead Sponsor:
University of Helsinki
Conditions:
Brain Ischemia
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
Hypothesis: Mild hypothermia using non-invasive temperature management system in a stroke unit is safe and feasible in spontaneously breathing, alteplase-thrombolyzed patients with acute ischemic stro...
Detailed Description
Fever is associated with higher stroke mortality and poor outcome, but it is yet unknown whether this association is causative or epiphenomenal. In temporary brain ischemia rodent models hypothermia ...
Eligibility Criteria
Inclusion
- Acute ischemic hemispheric stroke treated with Actilyse(tPA)-thrombolysis according to Meilahti protocol
- NIHSS 7-20 (after thrombolysis) or a significant paresis of arm or leg (NIHSS 3, no movement against gravity) or a significant dysphasia (NIHSS 2-3) despite of the total NIHSS score
- Symptom onset within 6 hour
Exclusion
- Platelet count \< 75,000/mm3
- Known coagulopathy (INR spontaneously \>1.5)
- Hemodynamical unstability
- Recent history of angina pectoris or acute myocardial infarction
- Sepsis within 72 hours
- Pregnancy
- Pre-existing neurological disability with modified Rankin Scale Score\>2
- Known allergy or intolerance to buspirone, dexmedetomidine, meperidine
- Intracranial hemorrhage in brain CT scan
- Intracranial mass lesion (i.e., abscess, tumor, or infection)
- Participation in an other therapy trial within last 3 months
- Hypothermia- treatment cannot be initiated within 6 hours of symptom onset
- Protocol violation in thrombolytic therapy
- Any condition where researchers assume that the patient is not suitable (must be reasoned)
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00987922
Start Date
July 1 2007
End Date
September 1 2011
Last Update
September 20 2011
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