NCT02750150

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2013

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2013

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2016

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
Last Updated

April 22, 2026

Status Verified

April 1, 2016

Enrollment Period

2.8 years

First QC Date

April 5, 2016

Last Update Submit

April 17, 2026

Conditions

TraumaCoagulopathy

Outcome Measures

Primary Outcomes (1)

  • fibrinogen concentration (clauss)

    45 minutes after the admission on day 1 after trauma

Secondary Outcomes (1)

  • 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

Study Arms (2)

Freezed-dried plasma

EXPERIMENTAL

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

Fresh-frozen plasma

ACTIVE COMPARATOR

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

Interventions

Freezed-dried plasmaDRUG

early transfusion of 4 units of freezed dried plasma

Freezed-dried plasma
Fresh-frozen plasmaDRUG
Fresh-frozen plasma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Emergency
  • Trauma patient admitted in participating trauma care centers
  • Severe bleeding requiring transfusion with 4 units of red blood cells and 4 emergency plasma.

You may not qualify if:

  • Patient taking anticoagulants
  • Patients who have received hemostatic treatment during transport (tranexamic -acid excluded)
  • Minor Patient
  • Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency unit, Salengro hospital,

Lille, France

Location

Related Publications (1)

  • Garrigue D, Godier A, Glacet A, Labreuche J, Kipnis E, Paris C, Duhamel A, Resch E, Bauters A, Machuron F, Renom P, Goldstein P, Tavernier B, Sailliol A, Susen S. French lyophilized plasma versus fresh frozen plasma for the initial management of trauma-induced coagulopathy: a randomized open-label trial. J Thromb Haemost. 2018 Mar;16(3):481-489. doi: 10.1111/jth.13929. Epub 2018 Jan 22.

    PMID: 29274254RESULT

MeSH Terms

Conditions

Wounds and InjuriesHemostatic Disorders

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Sophie Susen, MD,PhD

    University Hospital, Lille

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2016

First Posted

April 25, 2016

Study Start

July 9, 2013

Primary Completion

April 17, 2016

Study Completion

April 17, 2016

Last Updated

April 22, 2026

Record last verified: 2016-04

Locations

FR(1)