Severe TraumaNCT03020849
Predictors of Hypofibrinogenemia in Severe Trauma
An observational study of Severe Trauma, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
In this retrospective and prospective study, the aim is to determine a score for predicting a fibrinogen <1.5g/L (corresponding to European threshold of Directors recommendations of fibrinogen concentrates) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Trauma
- How many people
- 1,038 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2011to Mar 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
Who may be able to join
- age > 18
- severe trauma
Who cannot join
- age <18
Trial locations and contacts
2 sites in 1 country.
France2 sites
HEH - Hospices Civils de Lyon
Lyon, 69003
CHLS, Hospices Civils de Lyon
Pierre-Bénite, 69495
About this study
Official title: Can we Define a Clinical Score for Predicting of Hypofibrinogenemia in Severe Trauma
In this retrospective and prospective study, the aim is to determine a score for predicting a fibrinogen <1.5g/L (corresponding to European threshold of Directors recommendations of fibrinogen concentrates)
- Conditions
- Severe Trauma
- Keywords
- hypofibrinogenemia, prediction score, severe trauma
- Medical subject headings
- Wounds and Injuries, Afibrinogenemia
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of fibrinogen in blood sample at hospitalisation
This fibrinogen rate is correlated to pre-hospital and admission clinical parameters (trauma type, physiologic status, treatments administered, biologic checkup) to predict fibrinogenemia at hospitalisation
Measured: day 0 (at hospitalisation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startJan 2011
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe TraumaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Prospective
- Enrolment
- 1,038 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020849
- Sponsor's protocol ID
- 69HCL17_0015
- Status last verified
- Jan 2017
- First submitted
- 10 Jan 2017
- Last updated
- 28 Jul 2017
- 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 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can we Define a Clinical Score for Predicting of Hypofibrinogenemia in Severe Trauma
- ClinicalTrials.gov ID
- NCT03020849
- Acronym / sponsor ID
- 69HCL17_0015
- Conditions
- Severe Trauma
- Keywords
- hypofibrinogenemia, prediction score, severe trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,038 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 13 Jan 2017 (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.
In this retrospective and prospective study, the aim is to determine a score for predicting a fibrinogen <1.5g/L (corresponding to European threshold of Directors recommendations of fibrinogen concentrates)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- severe trauma
Key inclusion criteria (2 listed)
- age > 18
- severe trauma
Key exclusion criteria (1 listed)
- age <18
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
rate of fibrinogen in blood sample at hospitalisation
Time frame: day 0 (at hospitalisation)
This fibrinogen rate is correlated to pre-hospital and admission clinical parameters (trauma type, physiologic status, treatments administered, biologic checkup) to predict fibrinogenemia at hospitalisation
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 28 Jul 2017.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Trauma, run by Hospices Civils de Lyon at 2 sites 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 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 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
rate of fibrinogen in blood sample at hospitalisation (time frame: day 0 (at hospitalisation)). 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 28 Jul 2017.