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

Phase 3

Completed

• Conditions: Trauma; Coagulopathy
• Interventions: Drug: Freezed-dried plasma; Drug: Fresh-frozen plasma

• Registration Number: NCT02750150
• Lead Sponsor: University Hospital, Lille

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-04
• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-04-20
• Last Update Submitted: 2016-04-20
• Study First Posted: 2016-04-25
• Last Update Posted: 2016-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Freezed-dried plasma	Freezed-dried plasma	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)
Fresh-frozen plasma	Fresh-frozen 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)

Primary Outcome Measures

Name	Time	Method
fibrinogen concentration (clauss)	45 minutes after the admission on day 1 after trauma

Secondary Outcome Measures

Name	Time	Method
time frame of transfusion of 4 plasma	time range between the intention to transfuse plasma and the end of transfusion of 4 plasma within the first 6 hours after admission

Trial Locations

Locations (1)

Emergency unit, Salengro hospital,; 🇫🇷 Lille, France