Safty and Feasibility Study of Therapeutic Cooling in Acute Ischemic Stroke (COOLAID Øresund)
The Øresund Copenhagen-Malmø Acute Stroke Cooling Trial
1 other identifier
interventional
31
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2008
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 22, 2011
CompletedFirst Posted
Study publicly available on registry
December 28, 2011
CompletedDecember 28, 2011
December 1, 2011
3.1 years
December 22, 2011
December 27, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility and safety
Feasibility and safety defined as mortality and morbidity 3 months after ictus
3 month
Secondary Outcomes (1)
Modified Rankin Scale (mRS)
3 months
Study Arms (4)
TH - Endovacular alone
EXPERIMENTALPatients randomized to this arm are cooled to a bodytemperature of 33 degrees with an endovascular groin catheter (Copenhagen only).
TH - Endovascular + nasopharyngeal induction
EXPERIMENTALPatients randomized to this arm are cooled to a bodytemperature of 33 degrees with endovascular catheter along with nasopharyngeal induction (Copenhagen only).
Standard Treatment
NO INTERVENTIONPatients are treated with standard care in the stroke ward.
TH - Surface Cooling
EXPERIMENTALPatients 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)
Interventions
Patients are cooled with an endovascular (Alsius®, Zoll, USA) groin catether (9,3 french).
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.
Infusion of ice cold saline of 4°C (25 mL/kg body weight)followed by surface cooling
Eligibility Criteria
You may qualify if:
- National Institute of Health Stroke Scale (NIHSS) score on admission between 5 and 18
- Diagnosis of ischemic stroke verified by MRI, CT or CTP adjudicated by including physician
- Informed consent from patient or proxy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bispebjerg Hospitallead
- Malmö Universitycollaborator
Study Sites (1)
Bispebjerg Hospital
Copenhagen, Capital Region, DK-2400, Denmark
Related Publications (6)
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. doi: 10.1212/01.wnl.0000129840.66938.75.
PMID: 15277626BACKGROUNDHamann GF, Burggraf D, Martens HK, Liebetrau M, Jager 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. doi: 10.1161/01.STR.0000116866.60794.21. Epub 2004 Feb 19.
PMID: 14976330BACKGROUNDKrieger 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. doi: 10.1161/01.str.32.8.1847.
PMID: 11486115BACKGROUNDLyden 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. doi: 10.1016/j.jstrokecerebrovasdis.2005.01.001.
PMID: 17904009BACKGROUNDMilhaud 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.
PMID: 15632543BACKGROUNDSchwab 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. doi: 10.1161/hs0901.095394.
PMID: 11546893BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 22, 2011
First Posted
December 28, 2011
Study Start
October 1, 2008
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
December 28, 2011
Record last verified: 2011-12