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

Study Overview
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Brief Summary
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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.

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

Conditions
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Trauma, Coagulopathy

Intervention / Treatment
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* Drug: Freezed-dried plasma
* Drug: Fresh-frozen plasma


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Freezed-dried plasma<br>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<br>* early transfusion of 4 units of freezed dried plasma<br>|
| Active Comparator: Fresh-frozen plasma<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fibrinogen concentration (clauss) |  | 45 minutes after the admission on day 1 after trauma | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |