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

Bispebjerg Hospital

Status and phase: Completed; Phase 2

Conditions: Cerebral Infarction

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01500421

H-D-2008-105

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 4 patient groups

TH - Endovacular alone

Experimental group

Description:

Patients randomized to this arm are cooled to a bodytemperature of 33 degrees with an endovascular groin catheter (Copenhagen only).

Treatment:

Device: TH - Endovascular alone (Alsius®, Zoll, USA)

TH - Endovascular + nasopharyngeal induction

Experimental group

Description:

Patients randomized to this arm are cooled to a bodytemperature of 33 degrees with endovascular catheter along with nasopharyngeal induction (Copenhagen only).

Treatment:

Device: TH - Endovascular + nasopharyngeal induction (Alsius®, Zoll, USA) (Rhinochill®, Benechill, USA)

Standard Treatment

No Intervention group

Description:

Patients are treated with standard care in the stroke ward.

TH - Surface Cooling

Experimental group

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)

Treatment:

Device: Intravenous cold saline and surface cooling (Arctic Sun, Medivance, USA)