Hyperfibrinogenemia After Major Trauma

NCT ID: NCT02509390

Last Updated: 2015-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Major Trauma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Severe trauma patients

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

Group Type EXPERIMENTAL

Blood samples

Intervention Type PROCEDURE

Investigators analyze hematological parameters with blood sampled daily in severe trauma patients

Interventions

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Blood samples

Investigators analyze hematological parameters with blood sampled daily in severe trauma patients

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pauline PD DERAS, MD

Role: PRINCIPAL_INVESTIGATOR

Regional Trauma Center, Department of Anesthesiology and critical care, Lapeyronie University Hospital, Montpellier

Locations

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Department of Anesthesiology and critical care, Lapeyronie University Hospital

Montpellier, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pauline PD DERAS, MD

Role: CONTACT

+334 67 33 82 56

Sophie SB BRINGUIER, PharmD

Role: CONTACT

+334 67 33 82 56

Facility Contacts

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Pauline PD DERAS, MD

Role: primary

+334 67 33 82 56

Other Identifiers

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9239

Identifier Type: -

Identifier Source: org_study_id

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