788
Participants
Start Date
December 1, 2025
Primary Completion Date
May 1, 2029
Study Completion Date
May 1, 2029
Induced hypothermia at 33°C
"Cooling and maintenance phase :~The aim is to achieve the target temperature of 33±0.5°C within 60 minutes after randomization. The target temperature of 33±0.5°C and device setting of 33°C will be maintained until 28 hours after randomization.~\- Rewarming: Normothermia will be restored by gradual rewarming at a rate of 0.2°C/h.~\- After rewarming: After 40 hours, in those participants who are still comatose or sedated, normothermia (36.5-37.7°C) will be maintained until 72 hours after randomization, and active warming will be avoided."
Control normothermia
"Participants whose initial temperature is below 33°C may be actively rewarmed to 36.5°-37.7°C, at which point active rewarming will be stopped and passive rewarming performed according to the latest guidelines. Participants whose initial temperature is above 33°C will not be actively rewarmed to normothermia. The goal will be to maintain temperature no higher than 37.8°C.~After 40 hours, in those participants who are still comatose or sedated, normothermia (36.5-37.7°C) will be maintained until 72 hours after randomization, and active warming will be avoided."
CH de Rodez, Rodez
APHM - Hôpital Nord, Marseille
CHU de Caen, Caen
CH d'Angoulême, Angoulême
CHR d'Orléans, Orléans
CH Public du Cotentin, Cherbourg
Hôpital Edouard Herriot, Lyon
APHP-Hôpital Saint-Antoine, Paris
CHU Bocage, Dijon
Hôpital André Mignot, Le Chesnay
Hôpital Sainte-Musse, Toulon
Hôpital Privé Jacques Cartier, Massy
APHP - Hôpital Ambroise Paré, Paris
CHU Les Abymes, Pointe-à-Pitre
Hôpital Erasme, Brussels
CHU Charleroi, Charleroi
Hôpital Universitaire de Gand, Ghent
Hôpital Universitaire de Bruxelles, Jette
Clinique Saint-PIerre, Ottignies
CHU de Nantes, Nantes
CH de Roanne, Roanne
CH Dubois Brive, Brive-la-Gaillarde
Hôpital Simone Veil, Cannes
CHU Clermont-Ferrand, Clermont-Ferrand
CHD Vendée, La Roche-sur-Yon
CHRU- Hôpital Roger Salengro, Lille
CHU Dupuytren, Limoges
Hôpital de l'Archet, Nice
APHP- Hôpital Cochin, Paris
CHRU de Strasbourg, Strasbourg
CHRU de Tours, Tours
CH Brocéliande Atlantique, Vannes
Erasme University Hospital
OTHER
Nantes University Hospital
OTHER