Traumatic Brain InjuryBiotraumapNCT04543162
Usefulness of Biomarkers in the Management of Mild Traumatic Brain Injury in Adults (Biotraumap)
An observational study of Traumatic Brain Injury and Intracranial Injury, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The indication of cranial computed tomography (CCT) is difficult to define for patients with mild traumatic brain injury (mTBI). For mTBI patients with a medium risk of intracranial complications, CCT scans are indicated although 90% of them are normal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Intracranial Injury
- How many people
- 1,025 participants
- Where
- 1 siteFrance
- Study dates
- 2 Oct 2019to 28 Aug 2024
- 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: Patients with mild Traumatic Brain Injury
Who may be able to join
- Male and female patient, major
- Patient admitted to the Emergency Department for mTBI, with a medium risk of intracranial lesions according to the SFMU (French Emergency Medicine Society) criteria, for which an S100B protein assay is indicated:
- GCS score of 15 with at least one associated risk factor: amnesia facts more than 30 minutes before the mTBI loss of consciousness, anti platelet aggregating agent
- Time between mTBI and blood draw (for the S100B protein assay) less than 3 hours.
- Patient covered by a Social Security scheme.
Who cannot join
- Patient classified in the high risk group of intracranial lesions according to SFMU criteria :
- GCS score less than 15, 2 hours after the trauma
- Focused neurological deficit
- Post-traumatic convulsion
- Suspicion of open fracture of the skull or embarrassment
- Any sign of fracture of the base of the skull (hemotympanum, bilateral periorbital bruise, otorrhea or rhinorrhea of cerebrospinal fluid)
Show all 11Show fewer
- Treatment with anticoagulants
- More than one episode of vomiting.
- Patient classified in the group at low risk of intracranial lesions according to the SFMU criteria, presenting a GCS score of 15 without any criteria for moderate or high risk groups of intracranial lesions.
- Patient consulting for moderate or severe head trauma (GCS score less than 13).
- Refusal of the patient (signature of the opposition form).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usefulness of Biomarkers in the Management of Mild Traumatic Brain Injury in Adults
The indication of cranial computed tomography (CCT) is difficult to define for patients with mild traumatic brain injury (mTBI). For mTBI patients with a medium risk of intracranial complications, CCT scans are indicated although 90% of them are normal.
The interest of the S100B protein has been widely demonstrated in the management of mTBI in adults. Its serum concentration (for blood sampling drawn less than 3 hours after trauma) can accurately predict a normal CCT scan for mTBI patients with a medium risk of intracranial complications. That's why, serum assay of the S100B protein is routinely used in the Emergency Department of Clermont-Ferrand University Hospital for the treatment of patients with mTBI.
The objective of the study is to optimize the management strategy for mTBI patients by blood testing of new brain biomarkers. These biomarkers are synthesized by brain cells and are released into the blood in case of intracranial lesions.
Read the detailed description
Other biomarkers of brain damage, involved in the pathophysiology of head trauma, are also known. These are, for example, GFAP (Glial Fibrillary Acidic Protein), UCH-L1 (Ubiquitine Carboxy Terminal Hydrolase L1), NSE (Neurone Specific Enolase), Tau, SBDP (Spectrin Breakdown Products) or NFL (Neurofilament) protein. To date, the too limited number of studies doesn't enable the use of these biomarkers routinely. Therefore we will study the interest of these biomarkers in the management of adult patients' mTBI. We wish to set a collection of biological samples drawn from 1500 patients consulting for mTBI (with a medium risk of intracranial complications) at the Emergency Department of Clermont-Ferrand University Hospital, and requiring an assay of the S100B protein.
The study will take place over a period of 36 months at Clermont-Ferrand University Hospital. Patients cared for mTBI when they come to the Emergency Department will be recruited according to the inclusion criteria. In case of no opposition, when having their blood drawn, one more tube will be drawn per patient. Then, the obtained serum will be frozen at -80 ° C for the next assays of the cerebral biomarkers such as: GFAP, UCH-L1, NSE, Tau, SBDP, NFL, etc. A later 2-weeks' telephone call after the head trauma will be made by a member of the staff of the Department of Biochemistry and Molecular Genetics.
- Conditions
- Traumatic Brain Injury, Intracranial Injury
- Keywords
- Glasgow Coma Scale (GCS) score of 15, S100B, Mild Traumatic Brain Injury, Brain biomarkers, Cerebral biomarkers, Intracranial lesions
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion
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 |
|---|---|---|
| patients with Mild Traumatic Brain Injury | patients with Mild Traumatic Brain Injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic value of cerebral biomarkers GFAP
Evaluate the diagnostic value of cerebral biomarkers GFAP (ng/L)
Measured: Day 0
Diagnostic value of cerebral biomarkers UCH-L1
Evaluate the diagnostic value of cerebral biomarkers UCH-L1 (ng/L)
Measured: Day 0
Diagnostic value of cerebral biomarkers NSE
Evaluate the diagnostic value of cerebral biomarkers NSE (µg/L)
Measured: Day 0
Diagnostic value of cerebral biomarkers Tau
Evaluate the diagnostic value of cerebral biomarkers TAU (ng/L)
Measured: Day 0
Diagnostic value of cerebral biomarkers SBDP
Evaluate the diagnostic value of cerebral biomarkers SBDP (µg/L)
Measured: Day 0
Diagnostic value of cerebral biomarkers NFL
Evaluate the diagnostic value of cerebral biomarkers NFL (ng/L)
Measured: Day 0
Secondary outcomes (4)
Utility of serum biomarker measurement with respect to reduction of the cost of management
Calculate this cost reduction compared to the cost of a cerebral tomodensitometry
Measured: Day 0
Risk factors (antiplatelet agent) on biomarker results
Collect information from medical records and assess the impact on biomarker results from statistical tests
Measured: Day 0
risk factors (loss of consciousness) on biomarker results
Collect information from medical records and assess the impact on biomarker results from statistical tests
Measured: Day 0
risk factors (amnesia) on biomarker results
Collect information from medical records and assess the impact on biomarker results from statistical tests
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start2 Oct 2019
- Primary completion28 Aug 2024
- Study completion28 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- 1,025 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damien Bouvier, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543162
- Sponsor's protocol ID
- RNI 2019 BOUVIER (Biotraumap)
- Other IDs
- 2019-A01228-49
- Acronym
- Biotraumap
- Status last verified
- Oct 2024
- First submitted
- 26 Sep 2019
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Allouchery G, Moustafa F, Roubin J, Pereira B, Schmidt J, Raconnat J, Pic D, Sapin V, Bouvier D. Clinical validation of S100B in the management of a mild traumatic brain injury: issues from an interventional cohort of 1449 adult patients. Clin Chem Lab Med. 2018 Oct 25;56(11):1897-1904. doi: 10.1515/cclm-2018-0471.
PubMed 29924734Biberthaler P, Linsenmeier U, Pfeifer KJ, Kroetz M, Mussack T, Kanz KG, Hoecherl EF, Jonas F, Marzi I, Leucht P, Jochum M, Mutschler W. Serum S-100B concentration provides additional information fot the indication of computed tomography in patients after minor head injury: a prospective multicenter study. Shock. 2006 May;25(5):446-53. doi: 10.1097/01.shk.0000209534.61058.35.
PubMed 16680008Bouvier D, Oddoze C, Ben Haim D, Moustafa F, Legrand A, Alazia M, Jehle E, Schmidt J, Sapin V. [Interest of S100B protein blood level determination for the management of patients with minor head trauma]. Ann Biol Clin (Paris). 2009 Jul-Aug;67(4):425-31. doi: 10.1684/abc.2009.0347. French.
PubMed 19654082Calcagnile O, Unden L, Unden J. Clinical validation of S100B use in management of mild head injury. BMC Emerg Med. 2012 Oct 27;12:13. doi: 10.1186/1471-227X-12-13.
PubMed 23102492
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Biomarkers in the Management of Mild Traumatic Brain Injury in Adults
- ClinicalTrials.gov ID
- NCT04543162
- Acronym / sponsor ID
- Biotraumap / RNI 2019 BOUVIER (Biotraumap)
- Conditions
- Traumatic Brain Injury, Intracranial Injury
- Keywords
- Glasgow Coma Scale (GCS) score of 15, S100B, Mild Traumatic Brain Injury, Brain biomarkers, Cerebral biomarkers, Intracranial lesions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,025 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 28 Aug 2024 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 10 Sep 2020 (actual)
- 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.
The indication of cranial computed tomography (CCT) is difficult to define for patients with mild traumatic brain injury (mTBI). For mTBI patients with a medium risk of intracranial complications, CCT scans are indicated although 90% of them are normal.
The interest of the S100B protein has been widely demonstrated in the management of mTBI in adults. Its serum concentration (for blood sampling drawn less than 3 hours after trauma) can accurately predict a normal CCT scan for mTBI patients with a medium risk of intracranial complications. That's why, serum assay of the S100B protein is routinely used in the Emergency Department of Clermont-Ferrand University Hospital for the treatment of patients with mTBI.
The objective of the study is to optimize the management strategy for mTBI patients by blood testing of new brain biomarkers. These biomarkers are synthesized by brain cells and are released into the blood in case of intracranial lesions.
Detailed description
Other biomarkers of brain damage, involved in the pathophysiology of head trauma, are also known. These are, for example, GFAP (Glial Fibrillary Acidic Protein), UCH-L1 (Ubiquitine Carboxy Terminal Hydrolase L1), NSE (Neurone Specific Enolase), Tau, SBDP (Spectrin Breakdown Products) or NFL (Neurofilament) protein. To date, the too limited number of studies doesn't enable the use of these biomarkers routinely. Therefore we will study the interest of these biomarkers in the management of adult patients' mTBI. We wish to set a collection of biological samples drawn from 1500 patients consulting for mTBI (with a medium risk of intracranial complications) at the Emergency Department of Clermont-Ferrand University Hospital, and requiring an assay of the S100B protein.
The study will take place over a period of 36 months at Clermont-Ferrand University Hospital. Patients cared for mTBI when they come to the Emergency Department will be recruited according to the inclusion criteria. In case of no opposition, when having their blood drawn, one more tube will be drawn per patient. Then, the obtained serum will be frozen at -80 ° C for the next assays of the cerebral biomarkers such as: GFAP, UCH-L1, NSE, Tau, SBDP, NFL, etc. A later 2-weeks' telephone call after the head trauma will be made by a member of the staff of the Department of Biochemistry and Molecular Genetics.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with Mild Traumatic Brain Injury | – | –patients with Mild Traumatic Brain Injury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mild Traumatic Brain Injury
Key inclusion criteria (5 listed)
- Male and female patient, major
- Patient admitted to the Emergency Department for mTBI, with a medium risk of intracranial lesions according to the SFMU (French Emergency Medicine Society) criteria, for which an S100B protein assay is indicated:
- GCS score of 15 with at least one associated risk factor: amnesia facts more than 30 minutes before the mTBI loss of consciousness, anti platelet aggregating agent
- Time between mTBI and blood draw (for the S100B protein assay) less than 3 hours.
- Patient covered by a Social Security scheme.
Key exclusion criteria (11 listed)
- Patient classified in the high risk group of intracranial lesions according to SFMU criteria :
- GCS score less than 15, 2 hours after the trauma
- Focused neurological deficit
- Post-traumatic convulsion
- Suspicion of open fracture of the skull or embarrassment
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
Diagnostic value of cerebral biomarkers GFAP
Time frame: Day 0
Evaluate the diagnostic value of cerebral biomarkers GFAP (ng/L)
Diagnostic value of cerebral biomarkers UCH-L1
Time frame: Day 0
Evaluate the diagnostic value of cerebral biomarkers UCH-L1 (ng/L)
Diagnostic value of cerebral biomarkers NSE
Time frame: Day 0
Evaluate the diagnostic value of cerebral biomarkers NSE (µg/L)
Diagnostic value of cerebral biomarkers Tau
Time frame: Day 0
Evaluate the diagnostic value of cerebral biomarkers TAU (ng/L)
Diagnostic value of cerebral biomarkers SBDP
Time frame: Day 0
Evaluate the diagnostic value of cerebral biomarkers SBDP (µg/L)
Diagnostic value of cerebral biomarkers NFL
Time frame: Day 0
Evaluate the diagnostic value of cerebral biomarkers NFL (ng/L)
4 secondary outcomes
Utility of serum biomarker measurement with respect to reduction of the cost of management
Time frame: Day 0
Risk factors (antiplatelet agent) on biomarker results
Time frame: Day 0
risk factors (loss of consciousness) on biomarker results
Time frame: Day 0
risk factors (amnesia) on biomarker results
Time frame: Day 0
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 8 Oct 2024.
- Background: PubMed 29924734Allouchery G, Moustafa F, Roubin J, Pereira B, Schmidt J, Raconnat J, Pic D, Sapin V, Bouvier D. Clinical validation of S100B in the management of a mild traumatic brain injury: issues from an interventional cohort of 1449 adult patients. Clin Chem Lab Med. 2018 Oct 25;56(11):1897-1904. doi: 10.1515/cclm-2018-0471.
- Background: PubMed 16680008Biberthaler P, Linsenmeier U, Pfeifer KJ, Kroetz M, Mussack T, Kanz KG, Hoecherl EF, Jonas F, Marzi I, Leucht P, Jochum M, Mutschler W. Serum S-100B concentration provides additional information fot the indication of computed tomography in patients after minor head injury: a prospective multicenter study. Shock. 2006 May;25(5):446-53. doi: 10.1097/01.shk.0000209534.61058.35.
- Background: PubMed 19654082Bouvier D, Oddoze C, Ben Haim D, Moustafa F, Legrand A, Alazia M, Jehle E, Schmidt J, Sapin V. [Interest of S100B protein blood level determination for the management of patients with minor head trauma]. Ann Biol Clin (Paris). 2009 Jul-Aug;67(4):425-31. doi: 10.1684/abc.2009.0347. French.
- Background: PubMed 23102492Calcagnile O, Unden L, Unden J. Clinical validation of S100B use in management of mild head injury. BMC Emerg Med. 2012 Oct 27;12:13. doi: 10.1186/1471-227X-12-13.
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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.
Damien Bouvier principal investigator
University Hospital, Clermont-Ferrand
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 Traumatic Brain Injury and Intracranial Injury, run by University Hospital, Clermont-Ferrand 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 5 inclusion and 11 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 8 Oct 2024. 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?
Diagnostic value of cerebral biomarkers GFAP (time frame: Day 0). The study lists 6 primary outcomes in all. 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 NCT04543162, which also lists 4 linked publications.
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 8 Oct 2024.