Major TraumaNCT02509390
Hyperfibrinogenemia After Major Trauma
A study testing Blood samples in people with Major Trauma, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Assessment of the evolution of fibrinogen plasma level within the first ten days after major trauma in order to determine prevalence of hyperfibrinogenemia (Fg > 4 g/L) and its time to onset. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Trauma
- What is being tested?
- Blood samples
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to Dec 2015
- Phase
- Interventional
- 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
Who may be able to join
- Patients older than 18 years old.
- Polytrauma with ISS Score > 15
- Hospitalized patients in reanimation unit < 4h after trauma
- Informed consent
Who cannot join
- Patients in another study
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and critical care, Lapeyronie University Hospital
Montpellier, 34295
Pauline PD DERAS, MD, +334 67 33 82 56, p-deras@chu-montpellier.fr
About this study
Official title: Hyperfibrinogenemia Within the First Days After Major Trauma : Kinetic, Functionality, Impact of Fibrinogen Replacement Therapy and Trauma, Thrombosis Risk
Assessment of the evolution of fibrinogen plasma level within the first ten days after major trauma in order to determine prevalence of hyperfibrinogenemia (Fg > 4 g/L) and its time to onset.
Read the detailed description
In this study, investigators daily investigate fibrinogen plasma levels and fibrinogen antigen in severe trauma patients (Injury severity score > 15) within the first ten days. Investigators then modelize hyperfibrinogenemia profiles according to severity of injuries and physiopathologic mechanisms. Finally, investigators determine predisposing risk factors to develop hyperfibrinogenemia and assess the impact of fibrinogen replacement therapy in initial phase of management of major trauma.
- Conditions
- Major Trauma
- Being tested
- Blood samples
- Keywords
- Fibrinogen level, Hyperfibrinogenemia, Trauma, Thrombosis risk
- 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.
Blood samplesProcedure or surgery
Investigators analyze hematological parameters with blood sampled daily in severe trauma patients
| Study group | Role | What they receive |
|---|---|---|
| Severe trauma patients | Experimental | All severe trauma patients (ISS>15) admitted in our trauma center Blood samples (additional blood tubing) Receives: Procedure: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
daily fibrinogen level >4 g/L
the occurrence and delay of fibrinogen level > 4 g/L after major trauma
Measured: 10 days
Secondary outcomes (2)
assessing predisposing risk factors of hyperfibrinogenemia (> 4 g/l)
Initial chock status severity, vascular filling, initial acidose, hypothermia, trauma severity (ISS scores, Sequential Organ Failure Assessment (SOFA), IGS2), numbers and sites of lesions (AIS scores), severity of initial failure of fibrinogene, administration of fibrinogene at initial hemorrhagic phase…
Measured: 10 days
plasmatic fibrinogen level evolution
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startSep 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major TraumaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pauline PD DERAS, MD, Principal investigator, Regional Trauma Center, Department of Anesthesiology and critical care, Lapeyronie University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509390
- Sponsor's protocol ID
- 9239
- Status last verified
- Jul 2015
- First submitted
- 10 Dec 2013
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperfibrinogenemia Within the First Days After Major Trauma : Kinetic, Functionality, Impact of Fibrinogen Replacement Therapy and Trauma, Thrombosis Risk
- ClinicalTrials.gov ID
- NCT02509390
- Acronym / sponsor ID
- 9239
- Conditions
- Major Trauma
- Keywords
- Fibrinogen level, Hyperfibrinogenemia, Trauma, Thrombosis risk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 28 Jul 2015 (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.
Assessment of the evolution of fibrinogen plasma level within the first ten days after major trauma in order to determine prevalence of hyperfibrinogenemia (Fg > 4 g/L) and its time to onset.
Detailed description
In this study, investigators daily investigate fibrinogen plasma levels and fibrinogen antigen in severe trauma patients (Injury severity score > 15) within the first ten days. Investigators then modelize hyperfibrinogenemia profiles according to severity of injuries and physiopathologic mechanisms. Finally, investigators determine predisposing risk factors to develop hyperfibrinogenemia and assess the impact of fibrinogen replacement therapy in initial phase of management of major trauma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe trauma patients | Experimental | Procedure: Blood samplesAll severe trauma patients (ISS>15) admitted in our trauma center Blood samples (additional blood tubing) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than 18 years old.
- Polytrauma with ISS Score > 15
- Hospitalized patients in reanimation unit < 4h after trauma
- Informed consent
Key exclusion criteria (2 listed)
- Patients in another study
- Pregnant or lactating women
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 |
|---|---|---|
| Blood samplesInvestigators analyze hematological parameters with blood sampled daily in severe trauma patients | Procedure or surgery | Severe trauma patients |
Primary outcome
daily fibrinogen level >4 g/L
Time frame: 10 days
the occurrence and delay of fibrinogen level > 4 g/L after major trauma
2 secondary outcomes
assessing predisposing risk factors of hyperfibrinogenemia (> 4 g/l)
Time frame: 10 days
plasmatic fibrinogen level evolution
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
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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.
Pauline PD DERAS, MD principal investigator
Regional Trauma Center, Department of Anesthesiology and critical care, Lapeyronie University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples in people with Major Trauma, run by University Hospital, Montpellier 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Jul 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pauline PD DERAS, MD (+334 67 33 82 56, p-deras@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
daily fibrinogen level >4 g/L (time frame: 10 days). 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 2015; AzTrials last refreshed its copy on 4 Nov 2026.