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

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Lille

Criteria

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