Safty and Feasibility Study of Therapeutic Cooling in Acute Ischemic Stroke (COOLAID Øresund) - Full Text View

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:

MedlinePlus related topics: Hypothermia

U.S. FDA Resources

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:

De Georgia MA, Krieger DW, Abou-Chebl A, Devlin TG, Jauss M, Davis SM, Koroshetz WJ, Rordorf G, Warach S. Cooling for Acute Ischemic Brain Damage (COOL AID): a feasibility trial of endovascular cooling. Neurology. 2004 Jul 27;63(2):312-7.

Hamann GF, Burggraf D, Martens HK, Liebetrau M, Jäger G, Wunderlich N, DeGeorgia M, Krieger DW. Mild to moderate hypothermia prevents microvascular basal lamina antigen loss in experimental focal cerebral ischemia. Stroke. 2004 Mar;35(3):764-9. Epub 2004 Feb 19.

Krieger DW, De Georgia MA, Abou-Chebl A, Andrefsky JC, Sila CA, Katzan IL, Mayberg MR, Furlan AJ. Cooling for acute ischemic brain damage (cool aid): an open pilot study of induced hypothermia in acute ischemic stroke. Stroke. 2001 Aug;32(8):1847-54.

Lyden PD, Allgren RL, Ng K, Akins P, Meyer B, Al-Sanani F, Lutsep H, Dobak J, Matsubara BS, Zivin J. Intravascular Cooling in the Treatment of Stroke (ICTuS): early clinical experience. J Stroke Cerebrovasc Dis. 2005 May-Jun;14(3):107-14.

Milhaud D, Thouvenot E, Heroum C, Escuret E. Prolonged moderate hypothermia in massive hemispheric infarction: clinical experience. J Neurosurg Anesthesiol. 2005 Jan;17(1):49-53.

Schwab S, Georgiadis D, Berrouschot J, Schellinger PD, Graffagnino C, Mayer SA. Feasibility and safety of moderate hypothermia after massive hemispheric infarction. Stroke. 2001 Sep;32(9):2033-5.

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 May 16, 2013