COOL-Trial: Outcome With Invasive and Non-invasive Cooling After Cardiac Arrest
NCT ID: NCT00843297
Last Updated: 2010-02-02
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
PHASE4
120 participants
INTERVENTIONAL
2008-04-30
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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CG
Coolgard: invasive Cooling
Coolgard
invasive Cooling via femoral ICY-catheter
AS
ArcticSun: Surface-Cooling
ArcticSun
Noninvasive surface-cooling by saline-cooled thermo-vest
UnCOOL
No Cooling-Therapy due to non-operational cooling-devices
Conventional treatment
Intensive care-treatment without cooling
Interventions
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Coolgard
invasive Cooling via femoral ICY-catheter
ArcticSun
Noninvasive surface-cooling by saline-cooled thermo-vest
Conventional treatment
Intensive care-treatment without cooling
Eligibility Criteria
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Inclusion Criteria
* GCS 3
Exclusion Criteria
* Pregnancy
* Unstable Circulation instead of High-dose Inotropics
* Life-expectancy reducing concomitant illness
ALL
No
Sponsors
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University of Leipzig
OTHER
Responsible Party
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University of Leipzig, Heart Center
Principal Investigators
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Holger Thiele, Associate Professor
Role: PRINCIPAL_INVESTIGATOR
Study Chair
Undine Pittl, MD
Role: STUDY_DIRECTOR
Study Sub-Investigator
Locations
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University of Leipzig, Heart Center, Cardiology
Leipzig, , Germany
Countries
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References
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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.
Other Identifiers
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COOL-Trial
Identifier Type: -
Identifier Source: org_study_id
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