Hyperfibrinogenemia After Major Trauma

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02509390

Enrollment

150

Registered

2015-07-28

Start date

2014-09-30

Completion date

2015-12-31

Last updated

2015-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Trauma

Keywords

Fibrinogen level, Hyperfibrinogenemia, Trauma, Thrombosis risk

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.

Interventions

PROCEDUREBlood samples

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
assessing predisposing risk factors of hyperfibrinogenemia (> 4 g/l)	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	10 days	—

Countries

France

Contacts

Primary ContactPauline PD DERAS, MD

p-deras@chu-montpellier.fr+334 67 33 82 56

Backup ContactSophie SB BRINGUIER, PharmD

s-bringuierbranchereau@chu-montpellier.fr+334 67 33 82 56

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026