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

This study has been completed.
Sponsor:
Collaborator:
Malmö University
Information provided by (Responsible Party):
Derk W. Krieger MD, Ph.D, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01500421
First received: December 22, 2011
Last updated: December 27, 2011
Last verified: December 2011

December 22, 2011
December 27, 2011
October 2008
November 2011   (final data collection date for primary outcome measure)
Feasibility and safety [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
Feasibility and safety defined as mortality and morbidity 3 months after ictus
Same as current
Complete list of historical versions of study NCT01500421 on ClinicalTrials.gov Archive Site
Modified Rankin Scale (mRS) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
mRS score after 7 days and 3 months
Same as current
Not Provided
Not Provided
 
Safty and Feasibility Study of Therapeutic Cooling in Acute Ischemic Stroke (COOLAID Øresund)
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cerebral Infarction
  • 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
    Other Name: Arctic Sun, Medivance, USA
  • Experimental: TH - Endovacular alone
    Patients randomized to this arm are cooled to a bodytemperature of 33 degrees with an endovascular groin catheter (Copenhagen only).
    Intervention: Device: TH - Endovascular alone (Alsius®, Zoll, USA)
  • Experimental: TH - Endovascular + nasopharyngeal induction
    Patients randomized to this arm are cooled to a bodytemperature of 33 degrees with endovascular catheter along with nasopharyngeal induction (Copenhagen only).
    Intervention: Device: TH - Endovascular + nasopharyngeal induction (Alsius®, Zoll, USA) (Rhinochill®, Benechill, USA)
  • No Intervention: Standard Treatment
    Patients are treated with standard care in the stroke ward.
  • Experimental: TH - Surface Cooling
    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)
    Intervention: Device: Intravenous cold saline and surface cooling (Arctic Sun, Medivance, USA)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01500421
H-D-2008-105
Yes
Derk W. Krieger MD, Ph.D, Bispebjerg Hospital
Bispebjerg Hospital
Malmö University
Not Provided
Bispebjerg Hospital
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP