Ischemic Stroke Clinical Trial
Official title:
HAIS-SE (Hypothermia in Acute Ischemic Stroke - Surface Versus Endovascular Cooling): A Randomized Trial Comparing Surface Versus Endovascular Cooling in Awake Stroke Patients Treated With Thrombolysis
HAIS-SE is evaluating for the first time ever in a randomized controlled trial efficacy, tolerability, practicability and safety of endovascular versus surface cooling in awake stroke patients.
Mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac
arrest. Via animal models hypothermia has been identified as the most promising
neuroprotective therapy in focal cerebral ischemia as well. But the prove of clinical
benefit in patients with acute ischemic stroke is still missing: Most likely due to the
prolonged time window until hypothermia-induction (14 h) in previous studies. In addition,
feasibility of the method through which hypothermia is applied is crucial for a broad
implementation of hypothermia in stroke therapy. Surface versus endovascular cooling have
never been compared in a prospective trial in awake stroke patients.
HAIS-SE is evaluating for the first time ever in a randomized controlled trial efficacy,
tolerability, practicability and safety of endovascular versus surface cooling in awake
stroke patients.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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