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Completed

NCT Number: NCT02750150

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

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.

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Key information

Conditions

Trauma Cardiovascular Diseases Coagulopathy Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Emergency unit, Salengro hospital,

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Freezed-dried plasma

Drug

early transfusion of 4 units of freezed dried plasma

Fresh-frozen plasma

Drug

Primary outcomes

  1. fibrinogen concentration (clauss)

    Time frame: 45 minutes after the admission on day 1 after trauma

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: TrauCC

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 25, 2016
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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