Severe TraumaCoaguchekNCT02869737
Utility of Point-of-care Device for Rapid Determination of Cogulopathy in Trauma Patients
An observational study of Severe Trauma, run by University Hospital, Grenoble.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Severe Trauma
- What is being tested?
- Coagucheck, Roche, France
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admited for a suspicion of severe trauma wirth active bleeding in a level I trauma center
Who may be able to join
- Age > 15 y-o
- Admission for severe trauma
Who cannot join
- Patients under oral anticoagulant
About this study
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.
- Conditions
- Severe Trauma
- Being tested
- Coagucheck, Roche, France
- Keywords
- Point of Care Device; post traumatic coagulopathy
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coagucheck, Roche, FranceDevice
Capillary puncture for POC INR measurement
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between POC INR and laboratory INR using 3 classes: normal < 1.1, moderate : 1.1-1.5, severe: >1.5
Measured: Admission
Secondary outcomes (5)
Prediction of RBC transfusion
Measured: 24 hours post admission
Prediction of FFP transfusion
Measured: 24 hours post admission
In-hospital mortality assessed using patients' files
Measured: up to Day 28
Injury severity (ISS)
Measured: Day 1
Organ failure measured with the SOFA score at Day 1
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startJan 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe TraumaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869737
- Sponsor's protocol ID
- CECIC 2015-03
- Acronym
- Coaguchek
- Status last verified
- Aug 2016
- First submitted
- 9 Aug 2016
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Point-of-care Device for Rapid Determination of Cogulopathy in Trauma Patients
- ClinicalTrials.gov ID
- NCT02869737
- Acronym / sponsor ID
- Coaguchek / CECIC 2015-03
- Conditions
- Severe Trauma
- Keywords
- Point of Care Device; post traumatic coagulopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admited for a suspicion of severe trauma wirth active bleeding in a level I trauma center
Key inclusion criteria (2 listed)
- Age > 15 y-o
- Admission for severe trauma
Key exclusion criteria (1 listed)
- Patients under oral anticoagulant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coagucheck, Roche, FranceCapillary puncture for POC INR measurement | Device | – |
Primary outcome
Concordance between POC INR and laboratory INR using 3 classes: normal < 1.1, moderate : 1.1-1.5, severe: >1.5
Time frame: Admission
5 secondary outcomes
Prediction of RBC transfusion
Time frame: 24 hours post admission
Prediction of FFP transfusion
Time frame: 24 hours post admission
In-hospital mortality assessed using patients' files
Time frame: up to Day 28
Injury severity (ISS)
Time frame: Day 1
Organ failure measured with the SOFA score at Day 1
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
- Derived from this study: PubMed 28637514Mistral 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Trauma, run by University Hospital, Grenoble.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance between POC INR and laboratory INR using 3 classes: normal < 1.1, moderate : 1.1-1.5, severe: >1.5 (time frame: Admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02869737, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2016.