Hyperfibrinogenemia After Major Trauma

University Hospital Center (CHU)

Status: Unknown

Conditions: Major Trauma

Treatments: Procedure: Blood samples

Study type: Interventional

Funder types: Other

Identifiers

NCT02509390

9239

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Severe trauma patients

Experimental group

Description:

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

Treatment:

Procedure: Blood samples