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
  Purpose

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.


Condition Intervention Phase
Cerebral Infarction
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)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Øresund Copenhagen-Malmø Acute Stroke Cooling Trial

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Feasibility and safety [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
    Feasibility and safety defined as mortality and morbidity 3 months after ictus


Secondary Outcome Measures:
  • Modified Rankin Scale (mRS) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    mRS score after 7 days and 3 months


Enrollment: 31
Study Start Date: October 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TH - Endovacular alone
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)
Patients are cooled with an endovascular (Alsius®, Zoll, USA) groin catether (9,3 french).
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).
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.
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)
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01500421

Locations
Denmark
Bispebjerg Hospital
Copenhagen, Capital Region, Denmark, DK-2400
Sponsors and Collaborators
Bispebjerg Hospital
Malmö University
  More Information

Publications:
Responsible Party: Derk W. Krieger MD, Ph.D, Principal Investigator, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01500421     History of Changes
Other Study ID Numbers: H-D-2008-105
Study First Received: December 22, 2011
Last Updated: December 27, 2011
Health Authority: Denmark: National Board of Health
Sweden: The National Board of Health and Welfare

Keywords provided by Bispebjerg Hospital:
Hypothermia, Induced

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on April 17, 2014