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Mild Traumatic Brain InjuryBRAININCT04032509

A Study of Biomarkers of Mild Traumatic BRAIN Injury

An observational study of Mild Traumatic Brain Injury, run by University Hospital, Grenoble at 16 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients with mild traumatic brain injury (mTBI) represent a burden of patients admitted to the emergency department. According to the guidelines, a cerebral CT scan is indicated after mTBI according to the specific conditions. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mild Traumatic Brain Injury
What is being tested?
2 x 5 mL blood sample
How many people
1,501 participants
Where
16 sitesin 2 countries
Study dates
10 Aug 2019to 28 Sep 2021
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: 1600 patients: 1300 patients in France and 300 patients in Spain

Who may be able to join

  • Patients >18 years old (France)
  • Mild TBI (GCS 13-15 on admission) within 12 hours after injury
  • Indication of brain CT scan:
  • neurological focal deficit
  • anterograde amnesia
  • Glasgow coma scale score <15 after 2 hours post-TBI
Show all 13Show fewer
  • suspicion of vault depression fracture
  • fracture of the basal skull
  • persisting nausea, vomiting or headache
  • post-TBI seizures
  • Pre-injury treatment with antithrombotic drugs
  • Loss of consciousness or amnesia with age >65 years, fall >1m or hit pedestrian
  • Other condition requiring CT scan according to the in-charge physician.

Who cannot join

  • GCS 3-12 on admission
  • Time of injury unknown
  • Time to injury exceeding 12 hours
  • Primary admission for non-traumatic neurological disorder (e.g., stroke, spontaneous intracranial hematoma)
  • Penetrating head trauma
  • Patient with mechanical ventilation
Show all 12Show fewer
  • Pre-injury neurological disorder affecting the assessment of neurological outcome: dementia, Parkinson's disease, multiple sclerosis, seizure disorder, brain tumor, and history of neurosurgery, stroke or transient ischemic attack (TIA) within the last 30 days
  • Venipuncture not feasible
  • No realization of brain CT-scan
  • Subject under judiciary control
  • Pregnant or breastfeeding woman
  • Subject in exclusion period of another study

Trial locations and contacts

16 sites in 2 countries.

16 sites in 2 countries

France12 sites

  • Centre Hospitalier Annecy Genevois

    Annecy

  • CHU Bordeaux

    Bordeaux

  • CHU Dijon

    Dijon

  • CHU Grenoble Alpes

    Grenoble

  • Hopital Edouard HERRIOT - HCL

    Lyon

  • Hopital Lyon Sud HCL

    Lyon

  • CHU Montpellier

    Montpellier

  • CHU Nantes

    Nantes

  • CHU Poitiers

    Poitiers

  • CHU Toulouse

    Toulouse

  • CHU Tours

    Tours

  • Hôpital Nord Ouest de Villefranche sur Saône

    Villefranche-sur-Saône

Other trials in France

Spain4 sites

  • Hospital de La Princesa

    Madrid

  • Hospital del Tajo

    Madrid

  • Hospital Gregorio Maranon

    Madrid

  • Hospital Universitario de 12 Octubre

    Madrid

Other trials in Spain

About this study

Official title: A Prospective Clinical Study of Biomarkers of Mild Traumatic BRAIN Injury

Patients with mild traumatic brain injury (mTBI) represent a burden of patients admitted to the emergency department. According to the guidelines, a cerebral CT scan is indicated after mTBI according to the specific conditions. However, variability exists regarding the respect of these CT scan indications, and less than 10% of patients will have visible brain lesions on CT scan. Recently, serum Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) biomarkers have shown ability to differentiate normal and abnormal CT scan findings after mTBI. These encouraging results prompted us to launch a prospective study using automated and quick measurements of GFAP and UCH-L1 biomarkers to validate these findings.

Being tested
2 x 5 mL blood sample
Medical subject headings
Brain Concussion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2 x 5 mL blood sampleOther

    2 x 5 mL blood sample to determine the performance of the automated VIDAS BTI platform in assessing serum concentrations of GFAP and UCH-L1 to rule out the need for a CT-scan after mTBI.

Study groups in NCT04032509
Study groupRoleWhat they receive
Mild TBIMild TBI (GCS 13-15 on admission) within 12 hours after injury
Receives: Other: 2 x 5 mL blood sample

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Performance of the VIDAS-BTI assay in terms of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and their corresponding lower limit of 95% confidence interval by comparison with brain CT scan findings.

    2 x 5mL blood sample

    Measured: 12 hours post Traumatic Brain Injury (TBI)

Secondary outcomes (7)

  1. Determination of the added value of the two biomarkers measurements to Transcranial Doppler (TCD) performed on admission to detect patients at risk of neurological worsening and patients allowed for a safe return home

    TCD measures at admission

    Measured: Admission

  2. Determination of the added value of the two biomarkers measurements to Transcranial Doppler (TCD) performed on admission to detect patients at risk of neurological worsening and patients allowed for a safe return home

    Neurological status at 1 week after TBI

    Measured: 7 days after traumatic brain injury (TBI)

  3. Determination of the added value of the two biomarkers measurements to Transcranial Doppler (TCD) performed on admission to detect patients at risk of neurological worsening and patients allowed for a safe return home

    Quality of life after brain injury (QOLIBRI) Questionnaire

    Measured: 7 days after traumatic brain injury (TBI)

  4. Determination the potential of the two biomarkers in predicting neurological outcome

    Extended Glasgow Outcome Scale (GOSE)

    Measured: 3 month after TBI

  5. Determination of the potential of the two biomarkers in predicting neurological outcome

    Quality of life after brain injury (QOLIBRI) Questionnaire)

    Measured: 3 month after TBI

  6. Determination of the potential of the two biomarkers in predicting neurological outcome

    EuroQuol 5 dimensions 5 level questionnaire (EQ-5D-5L)

    Measured: 3 month after TBI

  7. Determination of the potential of the two biomarkers in predicting neurological outcome

    Rivermead Post-concussion symptoms Questionnaire (RPQ)

    Measured: 3 month after TBI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2019
  2. Study start10 Aug 2019
  3. Primary completion30 Jun 2021
  4. Study completion28 Sep 2021

Resources

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
1,501 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04032509
Sponsor's protocol ID
38RC19.176
Other IDs
2019-A01525-52
Acronym
BRAINI
Status last verified
Aug 2020
First submitted
15 Jul 2019
Last updated
2 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lagares A, de la Cruz J, Terrisse H, Mejan O, Pavlov V, Vermorel C, Payen JF; of the BRAINI participants and investigators. An automated blood test for glial fibrillary acidic protein (GFAP) and ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) to predict the absence of intracranial lesions on head CT in adult patients with mild traumatic brain injury: BRAINI, a multicentre observational study in Europe. EBioMedicine. 2024 Dec;110:105477. doi: 10.1016/j.ebiom.2024.105477. Epub 2024 Nov 29.

    PubMed 39612652

  • Richard M, Lagares A, Bondanese V, de la Cruz J, Mejan O, Pavlov V, Payen JF; BRAINI investigators. Study protocol for investigating the performance of an automated blood test measuring GFAP and UCH-L1 in a prospective observational cohort of patients with mild traumatic brain injury: European BRAINI study. BMJ Open. 2021 Feb 25;11(2):e043635. doi: 10.1136/bmjopen-2020-043635.

    PubMed 33632753

Questions about this trial

What is this clinical trial studying?

An observational study of Mild Traumatic Brain Injury, run by University Hospital, Grenoble at 16 sites in 2 countries.

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 13 inclusion and 12 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 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in France, Spain. 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?

Performance of the VIDAS-BTI assay in terms of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and their corresponding lower limit of 95% confidence interval by comparison with brain CT scan findings. (time frame: 12 hours post Traumatic Brain Injury (TBI)). 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 NCT04032509, which also lists 2 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 2 Mar 2022.

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