Status:
COMPLETED
Clinical and Economical Interest of Endovascular Cooling in the Management of Cardiac Arrest (ICEREA Study)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Alsius Corporation
distributed in France by
Conditions:
Hypothermia
Heart Arrest
Eligibility:
All Genders
18-79 years
Phase:
PHASE4
Brief Summary
According to international guidelines, mild therapeutic hypothermia is recommended for resuscitated patients after cardiac arrest due to ventricular fibrillation. Whether external or internal cooling ...
Detailed Description
According to international guidelines, mild therapeutic hypothermia is recommended for resuscitated patients after experiencing cardiac arrest from cardiac origin: "unconscious adult patients with spo...
Eligibility Criteria
Inclusion
- Age between 18 and 79 years old
- Out-of-hospital cardiac arrest (OH-CA) due to a presumed cardiac etiology
- Delay between OH-CA and return of spontaneous circulation (ROSC) \< 60 minutes
- Delay between ROSC and starting cooling \< 240 minutes
- Patient not obeying verbal command after ROSC and prior to starting cooling
- Availability of the "CoolGard" device (ALSIUS product)
Exclusion
- Do not reanimate order or terminal disease before inclusion
- Known pregnancy
- Clinical hemorrhagic syndrome or known coagulopathy
- Contra-indication to device usage (such as femoral venous access impossible)
- Hypothermia at admission \< 30°C
- Etiology of OH-CA thought to be extra-cardiac (trauma, bleeding or anoxia)
- In hospital cardiac arrest
- Refractory shock (need for extra-corporeal life support)
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
389 Patients enrolled
Trial Details
Trial ID
NCT00392639
Start Date
November 1 2006
End Date
November 1 2009
Last Update
December 1 2009
Active Locations (1)
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1
Teaching Lariboisière Hospital
Paris, France, 75010