NCT02869737

Brief Summary

Traumatic coagulopathy is frequent and is an independent risk factor of mortality. Its detection mainly relies upon classic biological test like the prothrombin time and the international normaliezd ratio (INR). These tests are not available at the bedside. Point of care (POC) device for INR measurement are now available like the Coaguchek, Roche, France. The aim of the present study is to test the correlation between the POC INR and the laboratory INR.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Status
completed

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

Study Start

First participant enrolled

January 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 17, 2016

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

1.4 years

First QC Date

August 9, 2016

Last Update Submit

August 12, 2016

Conditions

Severe Trauma

Keywords

Point of Care Device; post traumatic coagulopathy

Outcome Measures

Primary Outcomes (1)

  • Concordance between POC INR and laboratory INR using 3 classes: normal < 1.1, moderate : 1.1-1.5, severe: >1.5

    Admission

Secondary Outcomes (5)

  • Prediction of RBC transfusion

    24 hours post admission

  • Prediction of FFP transfusion

    24 hours post admission

  • In-hospital mortality assessed using patients' files

    up to Day 28

  • Injury severity (ISS)

    Day 1

  • Organ failure measured with the SOFA score at Day 1

    Day 1

Interventions

Coagucheck, Roche, FranceDEVICE

Capillary puncture for POC INR measurement

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admited for a suspicion of severe trauma wirth active bleeding in a level I trauma center

You may qualify if:

  • Age \> 15 y-o
  • Admission for severe trauma

You may not qualify if:

  • Patients under oral anticoagulant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Mistral T, Boue Y, Bosson JL, Manhes P, Greze J, Brun J, Albaladejo P, Payen JF, Bouzat P. Performance of point-of-care international normalized ratio measurement to diagnose trauma-induced coagulopathy. Scand J Trauma Resusc Emerg Med. 2017 Jun 21;25(1):59. doi: 10.1186/s13049-017-0404-y.

    PMID: 28637514DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2016

First Posted

August 17, 2016

Study Start

January 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 17, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share