NCT02509390

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2013

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
11 months until next milestone

First Posted

Study publicly available on registry

July 28, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 28, 2015

Status Verified

July 1, 2015

Enrollment Period

1.2 years

First QC Date

December 10, 2013

Last Update Submit

July 27, 2015

Conditions

Major Trauma

Keywords

Fibrinogen levelHyperfibrinogenemiaTraumaThrombosis risk

Outcome Measures

Primary Outcomes (1)

  • daily fibrinogen level >4 g/L

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

    10 days

Secondary Outcomes (2)

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

    10 days

  • plasmatic fibrinogen level evolution

    10 days

Study Arms (1)

Severe trauma patients

EXPERIMENTAL

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

Procedure: Blood samples

Interventions

Blood samplesPROCEDURE

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

Severe trauma patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients older than 18 years old.
  • Polytrauma with ISS Score \> 15
  • Hospitalized patients in reanimation unit \< 4h after trauma
  • Informed consent

You may not qualify if:

  • Patients in another study
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and critical care, Lapeyronie University Hospital

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Pauline PD DERAS, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pauline PD DERAS, MD

CONTACT

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

Sophie SB BRINGUIER, PharmD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2013

First Posted

July 28, 2015

Study Start

September 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

July 28, 2015

Record last verified: 2015-07

Locations

FR(1)