Early Administration of Prothrombin Concentrate Complex in Patients With Acute Hemorrhage Following Severe Trauma

PHASE3CompletedINTERVENTIONAL
Enrollment

350

Participants

Timeline

Start Date

December 29, 2017

Primary Completion Date

August 31, 2021

Study Completion Date

June 15, 2022

Conditions
Shock, Hemorrhagic
Interventions
DRUG

Pro-Thrombin Concentrate Complex

Patient at risk of massive hemorrhage will be managed with standard care with 1ml/kg PCC.

DRUG

NaCl 0.9%

Patient at risk of massive hemorrhage will be managed with standard care with 1ml/kg Saline solution.

Trial Locations (12)

13915

AP-HM - Marseille Nord, Marseille

34090

Montpellier University Hospital, Montpellier

59035

Lille University Hospital, Lille

67000

Strasbourg University Hospital, Strasbourg

69003

HCL - Hôpital Edouard Herriot, Lyon

69495

HCL - Lyon Sud, Pierre-Bénite

74370

Annecy University Hospital, Annecy

75651

AP-HP Pitié Salpetrière, Paris

92110

AP-HP Beaujon, Clichy

94275

AP-HP Kremlin Bicêtre, Le Kremlin-Bicêtre

Unknown

Grenoble University Hospital, Grenoble

44 093

Nantes University Hospital, Nantes

All Listed Sponsors
lead

University Hospital, Grenoble

OTHER

NCT03218722 - Early Administration of Prothrombin Concentrate Complex in Patients With Acute Hemorrhage Following Severe Trauma | Biotech Hunter | Biotech Hunter