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

Completed

Phase 2 Results N/A

Trial Description

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

Interventions

  • TH - Endovascular alone (Alsius®, Zoll, USA) Device
    Intervention Desc: Patients are cooled with an endovascular (Alsius®, Zoll, USA) groin catether (9,3 french).
    ARM 1: Kind: Experimental
    Label: TH - Endovacular alone
    Description: Patients randomized to this arm are cooled to a bodytemperature of 33 degrees with an endovascular groin catheter (Copenhagen only).
  • TH - Endovascular + nasopharyngeal induction (Alsius®, Zoll, USA) (Rhinochill®, Benechill, USA) Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: TH - Endovascular + nasopharyngeal induction
    Description: Patients randomized to this arm are cooled to a bodytemperature of 33 degrees with endovascular catheter along with nasopharyngeal induction (Copenhagen only).
  • Intravenous cold saline and surface cooling (Arctic Sun, Medivance, USA) Device
    Other Names: Arctic Sun, Medivance, USA
    Intervention Desc: Infusion of ice cold saline of 4°C (25 mL/kg body weight)followed by surface cooling
    ARM 1: Kind: Experimental
    Label: TH - Surface Cooling
    Description: 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)

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Feasibility and safety 3 month Yes
Secondary Modified Rankin Scale (mRS) 3 months Yes

Sponsors