Wounds and InjuryAPPNCT02884999
Management of Bleeding and Coagulopathy in Trauma and Compliance to European Trauma Guidelines
An observational study of Wounds and Injury and Bleeding, run by University Hospital, Brest at 1 site in France.
Trial summary
This cohort study describes the epidemiology of trauma patients and their management in a French academic trauma center. It also aims to determine what recommendations from the European trauma guidelines is applied in routine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds and Injury, Bleeding
- How many people
- 145 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to Nov 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Severe trauma patients
Who may be able to join
- Trauma patients with injury severity score equal to or higher than 16 year old admitted to the Brest academic trauma centre within the 24 hours following the trauma
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This cohort study describes the epidemiology of trauma patients and their management in a French academic trauma center. It also aims to determine what recommendations from the European trauma guidelines is applied in routine.
Read the detailed description
Severe trauma is responsible for more than 5 millions of deaths annually worldwide. Haemorrhagic shock secondary to uncontrolled bleeding is the leading cause of preventable death in this population, making bleeding and coagulopathy treatment a key element of the early phase of trauma management. European trauma guidelines have been developed to help clinicians in severe trauma management and improve bleeding and coagulopathy treatment in this population. Investigating who these guidelines are followed in routine is crucial to identify opportunities to improve early management of bleeding severe trauma patients.
- Conditions
- Wounds and Injury, Bleeding
- Keywords
- trauma, bleeding, coagulopathy, guidelines compliance, recommendation, transfusion
- Medical subject headings
- Wounds and Injuries, Hemorrhage, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| severe trauma patients | Severe trauma patients admitted to the site in the first 24 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients treated as per studied guidelines
Measured: first 24 hours of trauma management
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startMay 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile Aubron, Study director, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884999
- Sponsor's protocol ID
- APP
- Acronym
- APP
- Status last verified
- Aug 2016
- First submitted
- 19 Aug 2016
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Bleeding and Coagulopathy in Trauma and Compliance to European Trauma Guidelines
- ClinicalTrials.gov ID
- NCT02884999
- Acronym / sponsor ID
- APP / APP
- Conditions
- Wounds and Injury, Bleeding
- Keywords
- trauma, bleeding, coagulopathy, guidelines compliance, recommendation, transfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 31 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.
This cohort study describes the epidemiology of trauma patients and their management in a French academic trauma center. It also aims to determine what recommendations from the European trauma guidelines is applied in routine.
Detailed description
Severe trauma is responsible for more than 5 millions of deaths annually worldwide. Haemorrhagic shock secondary to uncontrolled bleeding is the leading cause of preventable death in this population, making bleeding and coagulopathy treatment a key element of the early phase of trauma management. European trauma guidelines have been developed to help clinicians in severe trauma management and improve bleeding and coagulopathy treatment in this population. Investigating who these guidelines are followed in routine is crucial to identify opportunities to improve early management of bleeding severe trauma patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| severe trauma patients | – | –Severe trauma patients admitted to the site in the first 24 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Severe trauma patients
Key inclusion criteria (1 listed)
- Trauma patients with injury severity score equal to or higher than 16 year old admitted to the Brest academic trauma centre within the 24 hours following the trauma
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients treated as per studied guidelines
Time frame: first 24 hours of trauma management
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 31 Aug 2016.
- 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.
Cécile Aubron study director
CHRU de Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds and Injury and Bleeding, run by University Hospital, Brest at 1 site in France.
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 1 inclusion and 0 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 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Number of patients treated as per studied guidelines (time frame: first 24 hours of trauma management). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2016.