Acute traumatic coagulopathy (ATC) is common in severe trauma patients (around 25 to 30% of patients with severe trauma) and is associated with increased mortality. ATC is associated with fibrinogen and clotting factors deficiencies. Therefore, ATC management relies on early administration of fibrinogen and blood products in case of massive transfusion with a 1:1 or 1:2 ratio between Fresh Frozen Plasma (FFP) and Red Blood Cells (RBC). This strategy relies on fast supply of FFP. To overcome delay for FFP ordering, transport and defrosting, the PROCOAG study proposes to use prothrombrin concentrate complex (PCC) as alternative to treat coagulation factor deficiency. PCC is readily available upon hospital arrival. In addition to fibrinogen treatment, it is thought that PCC can be efficient in ATC management, while reducing risks associated with massive transfusion. ProCoag is a randomized, controlled, double-blinded, parallel clinical trial aiming at showing superiority of early PPC+ fibrinogen strategy on fibrinogen only strategy for the management of patients at risk of massive transfusion. Early administration of PPC should optimize patient blood management and therefore reduce blood products transfused within the first 24 hours following a severe trauma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
350
Patient at risk of massive hemorrhage will be managed with standard care with 1ml/kg PCC.
Patient at risk of massive hemorrhage will be managed with standard care with 1ml/kg Saline solution.
Annecy University Hospital
Annecy, France
AP-HP Beaujon
Clichy, France
Grenoble University Hospital
Grenoble, France
AP-HP Kremlin Bicêtre
Le Kremlin-Bicêtre, France
Lille University Hospital
Lille, France
HCL - Hôpital Edouard Herriot
Lyon, France
AP-HM - Marseille Nord
Marseille, France
Montpellier University Hospital
Montpellier, France
Nantes University Hospital
Nantes, France
AP-HP Pitié Salpetrière
Paris, France
...and 2 more locations
Labile blood products transfused in the first 24 hours
This outcome is measured in number of bags administered
Time frame: 24 hours following hospital admission
RBC (Red Blood Cells) transfused in the first 24 hours
This outcome is measured in number of bags administered
Time frame: 24 hours following hospital admission
FFP transfused in the first 24 hours
This outcome is measured in number of bags administered
Time frame: 24 hours following hospital admission
Platelets transfused in the first 24 hours
This outcome is measured in number of bags administered
Time frame: 24 hours following hospital admission
Time to achieve Prothrombin ratio < 1.5
Time frame: Within the first 24 hours
Time to hemostasis
Hemostasis is defined as bleeding control in the surgical field or resolution of contrast blush after embolization during interventional radiology
Time frame: Within the first 24 hours following admission
Thrombo-embolic events
Time frame: ICU stay (an average of 28 days)
Mortality
Time frame: 24 hours and Day 28
ICU-free days
Number of in-hospital days outside Intensive Care Unit (ICU)
Time frame: Hospital stay (an average of 28 days)
Ventilator-Free Days
Number of days without mechanical ventilation
Time frame: ICU stay (an average of 21 days)
Hospital-free days
Number of days outside hospital
Time frame: Within the first 28 days
Glasgow Outcome Scale Extended (GOSE)
Time frame: Day 28
Hospitalisation status
Time frame: Day 28
Cost of the strategy
Time frame: Day 8 and Day 28
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