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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02750150

Acronym

TrauCC

Enrollment

Registered

2016-04-25

Start date

2013-07-09

Completion date

2016-04-17

Last updated

2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coagulopathy, Trauma

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.

Interventions

DRUGFreezed-dried plasma

early transfusion of 4 units of freezed dried plasma

DRUGFresh-frozen plasma

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
fibrinogen concentration (clauss)	45 minutes after the admission on day 1 after trauma

Secondary

Measure	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

Countries

France

Contacts

STUDY_CHAIRSophie Susen, MD,PhD

University Hospital, Lille

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026