COOL
Clinical and Neurological Outcome With Two Different Cooling Methods (Invasive and Non-invasive) After Sudden Cardiac Arrest
Sponsor study identifier
interventional
120
1 country
1
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Actual (reported)Study Completion
January 2010
Actual (reported)Sudden cardiac arrest (SCA) remains one of the major leading causes of death. Cognitive deficits are common in survivors of SCA. Postresuscitative mild induced hypothermia (MIH) lowers mortality and reduces neurologic damage after cardiac arrest. The investigators evaluated the efficacy and side effects of therapeutic hypothermia in an unselected group of patients after SCA.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
February 12, 2009
Actual (reported)February 13, 2009
Actual (reported)December 2009
Actual (reported)January 2010
Actual (reported)Time to reach the target temperature
Twenty-four hours
NSE as a parameter for cerebral damage
Seventy-two hours
Neurologic outcome
Six months
Survival
Six months
Periprocedural complications
Seventy-two hours
Coolgard: invasive Cooling
ArcticSun: Surface-Cooling
No Cooling-Therapy due to non-operational cooling-devices
invasive Cooling via femoral ICY-catheter
Noninvasive surface-cooling by saline-cooled thermo-vest
University of Leipzig, Heart Center, Cardiology
Leipzig, 04289, Germany
Zeiner A, Holzer M, Sterz F, Behringer W, Schorkhuber W, Mullner M, Frass M, Siostrzonek P, Ratheiser K, Kaff A, Laggner AN. Mild resuscitative hypothermia to improve neurological outcome after cardiac arrest. A clinical feasibility trial. Hypothermia After Cardiac Arrest (HACA) Study Group. Stroke. 2000 Jan;31(1):86-94. doi: 10.1161/01.str.31.1.86.
Bernard SA, Gray TW, Buist MD, Jones BM, Silvester W, Gutteridge G, Smith K. Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia. N Engl J Med. 2002 Feb 21;346(8):557-63. doi: 10.1056/NEJMoa003289.
Holger Thiele, Associate Professor
Study Chair
Undine Pittl, MD
Study Sub-Investigator
First Submitted
February 12, 2009
First Posted
February 13, 2009
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Actual (reported)Comparing Therapeutic Hypothermia Using External and Internal Cooling for Post-Cardiac Arrest Patients
Intensive care-treatment without cooling
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Study Completion
January 2010
Actual (reported)Last Updated
February 2, 2010
Record last verified: 2010-01
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Source: ClinicalTrials.gov.
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