A Phase 3 interventional study of Freezed-dried plasma and Fresh-frozen plasma in Trauma and Coagulopathy, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by University Hospital, Lille · Phase 3, Interventional, and Treatment
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 42 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.
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Exclusion Criteria:
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)
Drug: Freezed-dried plasma
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)
Drug: Fresh-frozen plasma
early transfusion of 4 units of freezed dried plasma
fibrinogen concentration (clauss)
Time frame: 45 minutes after the admission on day 1 after trauma
time frame of transfusion of 4 plasma
Time frame: time range between the intention to transfuse plasma and the end of transfusion of 4 plasma within the first 6 hours after admission
Plan to share: Undecided
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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University Hospital, Lille