Safty and Feasibility Study of Therapeutic Cooling in Acute Ischemic Stroke (COOLAID Øresund)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Øresund Copenhagen-Malmø Acute Stroke Cooling Trial

Conditions
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Cerebral Infarction

Intervention / Treatment
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* Device: TH - Endovascular alone (Alsius®, Zoll, USA)
* Device: TH - Endovascular + nasopharyngeal induction (Alsius®, Zoll, USA) (Rhinochill®, Benechill, USA)
* Device: Intravenous cold saline and surface cooling (Arctic Sun, Medivance, USA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TH - Endovacular alone<br>Patients randomized to this arm are cooled to a bodytemperature of 33 degrees with an endovascular groin catheter (Copenhagen only). | Device: TH - Endovascular alone (Alsius®, Zoll, USA)<br>* Patients are cooled with an endovascular (Alsius®, Zoll, USA) groin catether (9,3 french).<br>|
| Experimental: TH - Endovascular + nasopharyngeal induction<br>Patients randomized to this arm are cooled to a bodytemperature of 33 degrees with endovascular catheter along with nasopharyngeal induction (Copenhagen only). | Device: TH - Endovascular + nasopharyngeal induction (Alsius®, Zoll, USA) (Rhinochill®, Benechill, USA)<br>* Patient are cooled with a groin endovascular catheter (Alsius®, Zoll, USA) + a nasopharyngeal induction catheter (Rhinochill®, Benechill, USA) in the nostrils. The nasopharyngeal induction is designed to give a more quick and localised brain cooling.<br>|
| No Intervention: Standard Treatment<br>Patients are treated with standard care in the stroke ward. | |
| Experimental: TH - Surface Cooling<br>Patients randomized to this arm are cooled to a bodytemperature of 33 degrees with cold saline infusion followed by surface cooling with Arctic Sun Cooling system, Medivance, USA (Malmø only) | Device: Intravenous cold saline and surface cooling (Arctic Sun, Medivance, USA)<br>* Infusion of ice cold saline of 4°C (25 mL/kg body weight)followed by surface cooling<br>* Other names: Arctic Sun, Medivance, USA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and safety | Feasibility and safety defined as mortality and morbidity 3 months after ictus | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale (mRS) | mRS score after 7 days and 3 months | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypothermia, Induced