Hyperfibrinogenemia After Major Trauma

Major Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02509390
• Other study ID #: 9239
• Status: Recruiting
• Phase: N/A
• First received: December 10, 2013
• Last updated: July 27, 2015
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: July 2015
• Source: University Hospital, Montpellier
• Contact: Pauline PD DERAS, MD
• Phone: +334 67 33 82 56
• Email: p-deras[@]chu-montpellier.fr
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Major Trauma
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
France	Department of Anesthesiology and critical care, Lapeyronie University Hospital	Montpellier Cedex 5

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	daily fibrinogen level >4 g/L	the occurrence and delay of fibrinogen level > 4 g/L after major trauma	10 days	No
Secondary	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…	10 days	No
Secondary	plasmatic fibrinogen level evolution		10 days	No