NCT01500421

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

The Øresund Copenhagen-Malmø Acute Stroke Cooling Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Bispebjerg Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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

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.

Conditions

• Cerebral Infarction

Interventions

Type	Name	Description
DEVICE	TH - Endovascular alone (Alsius®, Zoll, USA)	Patients are cooled with an endovascular (Alsius®, Zoll, USA) groin catether (9,3 french).
DEVICE	TH - Endovascular + nasopharyngeal induction (Alsius®, Zoll, USA) (Rhinochill®, Benechill, USA)	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.
DEVICE	Intravenous cold saline and surface cooling (Arctic Sun, Medivance, USA)	Infusion of ice cold saline of 4°C (25 mL/kg body weight)followed by surface cooling

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2011-12-28
• Last updated: 2011-12-28

Locations

1 site across 1 country: Denmark