Hyperfibrinogenemia After Major Trauma

July 27, 2015 updated by: University Hospital, Montpellier

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier Cedex 5, France, 34295
        • Recruiting
        • Department of Anesthesiology and critical care, Lapeyronie University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Severe trauma patients
All severe trauma patients (ISS>15) admitted in our trauma center Blood samples (additional blood tubing)
Procedure: Blood samples
Investigators analyze hematological parameters with blood sampled daily in severe trauma patients

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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…
10 days
plasmatic fibrinogen level evolution
Time Frame: 10 days
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Pauline PD DERAS, MD, Regional Trauma Center, Department of Anesthesiology and critical care, Lapeyronie University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

December 10, 2013

First Submitted That Met QC Criteria

July 27, 2015

First Posted (Estimate)

July 28, 2015

Study Record Updates

Last Update Posted (Estimate)

July 28, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9239

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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