Utility of Point-of-care Device for Rapid Determination of Cogulopathy in Trauma Patients (Coaguchek)

August 12, 2016 updated by: University Hospital, Grenoble
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients under oral anticoagulant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Concordance between POC INR and laboratory INR using 3 classes: normal < 1.1, moderate : 1.1-1.5, severe: >1.5
Time Frame: Admission
Admission

Secondary Outcome Measures

Outcome Measure
Time Frame
Prediction of RBC transfusion
Time Frame: 24 hours post admission
24 hours post admission
Prediction of FFP transfusion
Time Frame: 24 hours post admission
24 hours post admission
In-hospital mortality assessed using patients' files
Time Frame: up to Day 28
up to Day 28
Injury severity (ISS)
Time Frame: Day 1
Day 1
Organ failure measured with the SOFA score at Day 1
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

August 9, 2016

First Submitted That Met QC Criteria

August 12, 2016

First Posted (Estimate)

August 17, 2016

Study Record Updates

Last Update Posted (Estimate)

August 17, 2016

Last Update Submitted That Met QC Criteria

August 12, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CECIC 2015-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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