Safty and Feasibility Study of Therapeutic Cooling in Acute Ischemic Stroke (COOLAID Øresund)
NCT ID: NCT01500421
Last Updated: 2011-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
31 participants
INTERVENTIONAL
2008-10-31
2011-11-30
Brief Summary
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Patients randomized to therapeutic hypothermia are analgo-sedated and cooled to at temperature of 33 degrees for a period of 24 hours.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TH - Endovacular alone
Patients randomized to this arm are cooled to a bodytemperature of 33 degrees with an endovascular groin catheter (Copenhagen only).
TH - Endovascular alone (Alsius®, Zoll, USA)
Patients are cooled with an endovascular (Alsius®, Zoll, USA) groin catether (9,3 french).
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).
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.
Standard Treatment
Patients are treated with standard care in the stroke ward.
No interventions assigned to this group
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)
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
Interventions
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TH - Endovascular alone (Alsius®, Zoll, USA)
Patients are cooled with an endovascular (Alsius®, Zoll, USA) groin catether (9,3 french).
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Malmö University
OTHER
Bispebjerg Hospital
OTHER
Responsible Party
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Derk W. Krieger MD, Ph.D
Principal Investigator
Locations
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Bispebjerg Hospital
Copenhagen, Capital Region, Denmark
Countries
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References
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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.
Hamann 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.
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. doi: 10.1161/01.str.32.8.1847.
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. doi: 10.1016/j.jstrokecerebrovasdis.2005.01.001.
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. doi: 10.1161/hs0901.095394.
Other Identifiers
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H-D-2008-105
Identifier Type: -
Identifier Source: org_study_id