NCT02750150

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

A Randomized Trial to Evaluate Freezed-dried Plasma in the Initial Management of Coagulopathy in Trauma Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Trauma
• Coagulopathy

Interventions

Type	Name	Description
DRUG	Freezed-dried plasma	early transfusion of 4 units of freezed dried plasma
DRUG	Fresh-frozen plasma

Timeline

• Start date: 2013-07-09
• Primary completion: 2016-04-17
• Completion: 2016-04-17
• First posted: 2016-04-25
• Last updated: 2025-12-16

Locations

1 site across 1 country: France