Freeze-dried Plasma in the Initial Management of Coagulopathy in Trauma Patients (TrauCC)

University Hospital, Lille

Status and phase: Completed; Phase 3

Conditions: Coagulopathy; Trauma

Treatments: Drug: Freezed-dried plasma; Drug: Fresh-frozen plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT02750150

2012-A00075-38 (Other Identifier)

2011_61

Details and patient eligibility

About

Knowledge and management of bleeding in severe trauma has changed. A specific coagulopathy is present in 40% of cases. It has a very early onset and this coagulopathy is associated with increased mortality. It must be detected and treated early, as illustrated by the military medical data, from the Iraq war and civilian medicine. However, fresh frozen plasma (FFP) requires a thawing step.The French army has encouraged the development of a freeze-dried plasma of innovative because viral inactivation and universal blood grouping, well tolerated, with a reduced risk of TRALI. This sophisticated therapeutic product can be administered after 6 minutes of reconstitution without the need for cross-matching. Nevertheless, its used is currently reserved for military purpose in overseas operations and needs to be evaluated for civil use. To this end, the investigators need to evaluate the impact on coagulopathy of an immediate availability of plasma.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Emergency
• Trauma patient admitted in participating trauma care centers
• Severe bleeding requiring transfusion with 4 units of red blood cells and 4 emergency plasma.
• Inclusion performed within the first 6 hours after trauma.

Exclusion criteria

• Patient taking anticoagulants
• Patients who have received hemostatic treatment during transport (tranexamic -acid excluded)
• Minor Patient
• Pregnant or breastfeeding women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Freezed-dried plasma

Experimental group

Description:

transfusion of 4 units of freezed dried plasma when available in patients at risk pf massive bleeding (transfusion of 4 red blood cells units in the first 6 hours after trauma)

Treatment:

Drug: Freezed-dried plasma

Fresh-frozen plasma

Active Comparator group

Description:

transfusion of 4 units of fresh frozen plasma when available in patients at risk pf massive bleeding (transfusion of 4 red blood cells units in the first 6 hours after trauma)

Treatment:

Drug: Fresh-frozen plasma