Status:
COMPLETED
Safty and Feasibility Study of Therapeutic Cooling in Acute Ischemic Stroke (COOLAID Øresund)
Lead Sponsor:
Bispebjerg Hospital
Collaborating Sponsors:
Malmö University
Conditions:
Cerebral Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is designed to investigate the safty and feasibility of therapeutic hypothermia in acute stroke patients. Soon after arrival in the stroke unit patients are randomized to either hypothermia...
Detailed Description
Ischemic stroke remains a diagnosis with limited treatment opportunities and a treatment with the ability to target patients outside the normal treatment window is wanted. Therapeutic hypothermia (TH...
Eligibility Criteria
Inclusion
- National Institute of Health Stroke Scale (NIHSS) score on admission between 5 and 18
- Inclusion within 24 hours after stroke onset
- Diagnosis of ischemic stroke verified by MRI, CT or CTP adjudicated by including physician
- Informed consent from patient or proxy
Exclusion
- Modified ranking scale (mRS)\>2 indicating significant disability before onset of stroke
- MRI or CT evidence for massive ischemic damage (\>50% Middle cerebral artery (MCA) territory)
- Severe concomitant diseases such as heart failure, chronic obstructive lung disease or known cancer
- Presently on anticoagulation treatment
- No informed consent from patient or proxy
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01500421
Start Date
October 1 2008
End Date
November 1 2011
Last Update
December 28 2011
Active Locations (1)
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1
Bispebjerg Hospital
Copenhagen, Capital Region, Denmark, DK-2400