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

Primary Purpose

Trauma, Coagulopathy

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Freezed-dried plasma

Fresh-frozen plasma

About this trial

This is an interventional treatment trial for Trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Emergency unit, Salengro hospital,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Freezed-dried plasma

Fresh-frozen plasma

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

fibrinogen concentration (clauss)

Secondary Outcome Measures

time frame of transfusion of 4 plasma

Full Information

NCT ID

NCT02750150

First Posted

April 5, 2016

Last Updated

April 20, 2016

Sponsor

University Hospital, Lille

1. Study Identification

Unique Protocol Identification Number

NCT02750150

Brief Title

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

Acronym

TrauCC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Lille

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trauma, Coagulopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Freezed-dried plasma

Arm Type

Experimental

Arm Description

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)

Arm Title

Fresh-frozen plasma

Arm Type

Active Comparator

Arm Description

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)

Intervention Type

Drug

Intervention Name(s)

Freezed-dried plasma

Intervention Description

early transfusion of 4 units of freezed dried plasma

Intervention Type

Drug

Intervention Name(s)

Fresh-frozen plasma

Primary Outcome Measure Information:

Title

fibrinogen concentration (clauss)

Time Frame

45 minutes after the admission on day 1 after trauma

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sophie Susen, MD,PhD

Organizational Affiliation

University Hospital, Lille

Official's Role

Study Chair

Facility Information:

Facility Name

Emergency unit, Salengro hospital,

City

Lille

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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