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CompletedNCT02869737CoaguchekUpdated Aug 17, 2016

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

An observational study in Severe Trauma, sponsored by University Hospital, Grenoble. Completed. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2016-08-17.

Sponsored by University Hospital, Grenoble · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
100
Ages
15 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Severe Trauma

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Keywords

  • Point of Care Device; post traumatic coagulopathy
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In context

Wounds and Injuries

5,085 studies on the registry are indexed under Wounds and Injuries; 849 are open to participants now.

This study's enrollment of 100 is below the median of 135 across 1,603 observational studies indexed under Wounds and Injuries.

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Lead sponsor

University Hospital, Grenoble is the lead sponsor of 835 studies on the registry; 207 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients under oral anticoagulant
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Study design

Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Interventions

  • DeviceCoagucheck, Roche, France

    Capillary puncture for POC INR measurement

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What researchers measure

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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 28637514 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2015, a primary completion of Jun 2016 and a completion of Jun 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 9, 2016
First posted
Aug 17, 2016
Start
Jan 2015
Primary completionActual
Jun 2016
CompletionActual
Jun 2016
Last update
Aug 17, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02869737
Lead sponsor
University Hospital, Grenoble
Responsible party
Sponsor
First posted
Aug 17, 2016
Start date
Jan 2015
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Aug 17, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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