Cerebral Infarction Clinical Trial
Official title:
The Øresund Copenhagen-Malmø Acute Stroke Cooling Trial
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 in the intensive care unit (ICU) or standard treatment in the stroke
ward.
Patients randomized to therapeutic hypothermia are analgo-sedated and cooled to at
temperature of 33 degrees for a period of 24 hours.
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) treatment has long been recognised as a treatment of patients
with global ischemia following caridac arrest.
This trial is designed to address the safty and feasibility of TH in acute stroke patients.
Patients arriving in our stroke ward are observed for 3 hours. Only non-remitting patients
are allowed into the trial.
Patients are randomized to either therapeutic hypothermia with endovascular catheter +
nasopharyngeal induction or endovascular catheter alone in the intensive care unit (ICU) (in
Copenhagen, Denmark) or intravenous cold saline infusion followed by surface cooling (in
Malmø, Sweden)versus standard treatment in a stoke unit.
Patients brought to the ICU are sedated and mechanically ventilated.
Therapeutic hypothermia is induced with a endovascular catether and a nasopharyngeal
catheter. Body temperature is lowered to 33 degrees and sustained for a period of 24 hours.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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