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

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Completed; Phase 3

Conditions: Shock, Hemorrhagic

Treatments: Drug: NaCl 0.9%; Drug: Pro-Thrombin Concentrate Complex

Study type: Interventional

Funder types: Other

Identifiers

NCT03218722

38RC16.046

Details and patient eligibility

About

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.

Enrollment: 350 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Primary admission for a severe trauma
• Out-of-hospital transfusion or RBC transfusion within the first hour following hospital admission
• Clinical prediction or ABC score (Assessment of Blood Consumption) ≥ 2 of massive transfusion defined by a transfusion of at least 10 CGR during the first 24 hours or 3 CGR during the first hour.
• Informed consent signed by a relative or emergency procedure

Exclusion criteria

• Cardiac arrest before randomisation
• Secondary transfer from another hospital (a technical stop is accepted)
• Post-traumatic lesions out of therapeutic resources with death expected in the hour following hospital admission
• Anti-coagulation treatment (K anti-vitamine, new oral anticoagulant)
• Pregnancy
• Hypersensitivity to active substances or one of the excipients of KANOKAD®
• Patient treated with an experimental medicine within the last 30 days
• Decision of therapeutic limitation before randomisation
• Patient protected by article L1121-7 of the French Public health code.
• Knowledge of a contraindication to the use of NaCl 0.9% at the dose of 1 mg/kg (hyperchloremia, hypernatremia...)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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350 participants in 2 patient groups, including a placebo group

PCC treatment

Experimental group

Description:

Conventional strategy for ATC management in addition to of intravenous Pro-Thrombin Concentrate Complex (25IU/kg factor IX)

Treatment:

Drug: Pro-Thrombin Concentrate Complex

Placebo treatment

Placebo Comparator group

Description:

Conventional strategy for ATC management without PCC (NaCl 0.9%)

Treatment:

Drug: NaCl 0.9%