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

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ClinicalTrials.gov Identifier: NCT02750150
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : April 25, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Trauma Coagulopathy Drug: Freezed-dried plasma Drug: Fresh-frozen plasma Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial to Evaluate Freezed-dried Plasma in the Initial Management of Coagulopathy in Trauma Patients
Study Start Date : July 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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)
Drug: Freezed-dried plasma
early transfusion of 4 units of freezed dried plasma

Active Comparator: 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)
Drug: Fresh-frozen plasma



Primary Outcome Measures :
  1. fibrinogen concentration (clauss) [ Time Frame: 45 minutes after the admission on day 1 after trauma ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750150


Locations
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France
Emergency unit, Salengro hospital,
Lille, France
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Study Chair: Sophie Susen, MD,PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02750150     History of Changes
Other Study ID Numbers: 2011_61
2012-A00075-38 ( Other Identifier: ID-RCB number, ANSM )
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: April 25, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Wounds and Injuries
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders