Hyperfibrinogenemia After Major Trauma

Not Applicable

• Conditions: Major Trauma
• Interventions: Procedure: Blood samples

• Registration Number: NCT02509390
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Assessment of the evolution of fibrinogen plasma level within the first ten days after major trauma in order to determine prevalence of hyperfibrinogenemia (Fg \> 4 g/L) and its time to onset.

Detailed Description

In this study, investigators daily investigate fibrinogen plasma levels and fibrinogen antigen in severe trauma patients (Injury severity score \> 15) within the first ten days. Investigators then modelize hyperfibrinogenemia profiles according to severity of injuries and physiopathologic mechanisms. Finally, investigators determine predisposing risk factors to develop hyperfibrinogenemia and assess the impact of fibrinogen replacement therapy in initial phase of management of major trauma.

Study Timeline

• Study First Submitted: 2013-12-10
• Study Start: 2014-09
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-27
• Last Update Submitted: 2015-07-27
• Study First Posted: 2015-07-28
• Last Update Posted: 2015-07-28
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients older than 18 years old.
• Polytrauma with ISS Score > 15
• Hospitalized patients in reanimation unit < 4h after trauma
• Informed consent

Exclusion Criteria

• Patients in another study
• Pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Severe trauma patients	Blood samples	All severe trauma patients (ISS\>15) admitted in our trauma center Blood samples (additional blood tubing)

Primary Outcome Measures

Name	Time	Method
daily fibrinogen level >4 g/L	10 days	the occurrence and delay of fibrinogen level \> 4 g/L after major trauma

Secondary Outcome Measures

Name	Time	Method
assessing predisposing risk factors of hyperfibrinogenemia (> 4 g/l)	10 days	Initial chock status severity, vascular filling, initial acidose, hypothermia, trauma severity (ISS scores, Sequential Organ Failure Assessment (SOFA), IGS2), numbers and sites of lesions (AIS scores), severity of initial failure of fibrinogene, administration of fibrinogene at initial hemorrhagic phase...
plasmatic fibrinogen level evolution	10 days

Trial Locations

Locations (1)

Department of Anesthesiology and critical care, Lapeyronie University Hospital; 🇫🇷 Montpellier Cedex 5, France