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Hyperfibrinogenemia After Major Trauma

Primary Purpose

Major Trauma

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Blood samples

About this trial

This is an interventional diagnostic trial for Major Trauma focused on measuring Fibrinogen level, Hyperfibrinogenemia, Trauma, Thrombosis risk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Department of Anesthesiology and critical care, Lapeyronie University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Severe trauma patients

Arm Description

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

Outcomes

Primary Outcome Measures

daily fibrinogen level >4 g/L

the occurrence and delay of fibrinogen level > 4 g/L after major trauma

Secondary Outcome Measures

assessing predisposing risk factors of hyperfibrinogenemia (> 4 g/l)

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

Full Information

NCT ID

NCT02509390

First Posted

December 10, 2013

Last Updated

July 27, 2015

Sponsor

University Hospital, Montpellier

1. Study Identification

Unique Protocol Identification Number

NCT02509390

Brief Title

Hyperfibrinogenemia After Major Trauma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Unknown status

Study Start Date

September 2014 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Trauma

Keywords

Fibrinogen level, Hyperfibrinogenemia, Trauma, Thrombosis risk

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Severe trauma patients

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Blood samples

Intervention Description

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

Primary Outcome Measure Information:

Title

daily fibrinogen level >4 g/L

Description

the occurrence and delay of fibrinogen level > 4 g/L after major trauma

Time Frame

10 days

Secondary Outcome Measure Information:

Title

assessing predisposing risk factors of hyperfibrinogenemia (> 4 g/l)

Description

Time Frame

10 days

Title

plasmatic fibrinogen level evolution

Time Frame

10 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pauline PD DERAS, MD

Phone

+334 67 33 82 56

p-deras@chu-montpellier.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Sophie SB BRINGUIER, PharmD

Phone

+334 67 33 82 56

s-bringuierbranchereau@chu-montpellier.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pauline PD DERAS, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Anesthesiology and critical care, Lapeyronie University Hospital

City

Montpellier Cedex 5

ZIP/Postal Code

34295

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pauline PD DERAS, MD

Phone

+334 67 33 82 56

p-deras@chu-montpellier.fr

12. IPD Sharing Statement

Learn more about this trial

Hyperfibrinogenemia After Major Trauma

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