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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02869737
Acronym
Coaguchek
Enrollment
100
Registered
2016-08-17
Start date
2015-01-31
Completion date
2016-06-30
Last updated
2016-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Trauma

Keywords

Point of Care Device; post traumatic coagulopathy

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.

Interventions

DEVICECoagucheck, Roche, France

Capillary puncture for POC INR measurement

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Patients under oral anticoagulant

Design outcomes

Primary

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

Secondary

MeasureTime frame
Prediction of RBC transfusion24 hours post admission
Prediction of FFP transfusion24 hours post admission
In-hospital mortality assessed using patients' filesup to Day 28
Injury severity (ISS)Day 1
Organ failure measured with the SOFA score at Day 1Day 1

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026