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OpenTrials
Completed

NCT Number: NCT02869737

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

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.

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Key information

Conditions

Severe Trauma Wounds and Injuries

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients under oral anticoagulant

Treatment and study plan

Coagucheck, Roche, France

Device

Capillary puncture for POC INR measurement

Primary outcomes

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

    Time frame: Admission

Secondary outcomes

  1. Prediction of RBC transfusion

    Time frame: 24 hours post admission

  2. Prediction of FFP transfusion

    Time frame: 24 hours post admission

  3. In-hospital mortality assessed using patients' files

    Time frame: up to Day 28

  4. Injury severity (ISS)

    Time frame: Day 1

  5. Organ failure measured with the SOFA score at Day 1

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: Coaguchek

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 17, 2016
Registry last updated
Aug 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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