CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 389 enrolled
Drug / intervention
Comparison of 2 cooling proceduresprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00392639
NCT00392639Phase 4Completed
CompareCT.gov

Clinical Interest of Endovascular Cooling in the Management of Cardiac Arrest: Impact on Mortality in a Randomized Medico-economical Trial (the ICEREA Study)

Assistance Publique - Hôpitaux de Paris·interventional·Posted Oct 26, 2006·Updated Dec 1, 2009

In Brief

A Phase 4 clinical trial evaluating Comparison of 2 cooling procedures for Hypothermia and Heart Arrest. Completed, enrolled 389 participants across 1 site.

Detailed 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 is superior in terms of prognosis or security remains unknown. The aim of this study is to evaluate in a randomized trial the clinical and economical interests of the endovascular cooling versus the conventional external cooling for the management of hypothermia after cardiac arrest.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypothermia, Heart Arrest
CountriesFrance
CollaboratorsAlsius Corporation, distributed in France by, IST Cardiology (Le Fresne Camilly, France)

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 26, 2006
Enrollment StartNov 1, 2006
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 19.7 years ago

Interventions

Comparison of 2 cooling proceduresprocedure

Comparison of 2 cooling procedures