Hyperfibrinogenemia After Major Trauma

Overview

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 Title of Study: “Hyperfibrinogenemia Within the First Days After Major Trauma : Kinetic, Functionality, Impact of Fibrinogen Replacement Therapy and Trauma, Thrombosis Risk”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2015

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.

Interventions

  • Procedure: Blood samples
    • Investigators analyze hematological parameters with blood sampled daily in severe trauma patients

Arms, Groups and Cohorts

  • Experimental: Severe trauma patients
    • All severe trauma patients (ISS>15) admitted in our trauma center Blood samples (additional blood tubing)

Clinical Trial Outcome Measures

Primary Measures

  • daily fibrinogen level >4 g/L
    • Time Frame: 10 days
    • the occurrence and delay of fibrinogen level > 4 g/L after major trauma

Secondary Measures

  • assessing predisposing risk factors of hyperfibrinogenemia (> 4 g/l)
    • Time Frame: 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
    • Time Frame: 10 days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Montpellier
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pauline PD DERAS, MD, Principal Investigator, Regional Trauma Center, Department of Anesthesiology and critical care, Lapeyronie University Hospital, Montpellier
  • Overall Contact(s)
    • Pauline PD DERAS, MD, +334 67 33 82 56, p-deras@chu-montpellier.fr

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