Last reviewed · How we verify
NCT04543162: Biotraumap
Usefulness of Biomarkers in the Management of Mild Traumatic Brain Injury in Adults (Biotraumap)
trial in Traumatic Brain Injury in 1,025 participants. Completed in 28 August 2024.
28 August 2024
Quick facts
| Lead sponsor | University Hospital, Clermont-Ferrand |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,025 |
| Start date | 2 October 2019 |
| Primary completion | 28 August 2024 |
| Estimated completion | 28 August 2024 |
| Sites | 1 location across France |
Conditions studied
- Traumatic Brain Injury — all drugs for Traumatic Brain Injury →
- Intracranial Injury — all drugs for Intracranial Injury →
Sponsor
University Hospital, Clermont-Ferrand
Who can join
18 and older, any sex, with Traumatic Brain Injury or Intracranial Injury. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
From Acute Injury to Chronic Neurodegeneration: Molecular Mechanisms Linking Secondary Brain Injury to Long-Term Pathology.
Kaniuk JK, Kumar D, Mazurek C, Khavari S, et al · · 2025 · cited 1× · PMID 40806328 · DOI 10.3390/ijms26157191
Verify or expand the search:
- PubMed search for NCT04543162
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Traumatic Brain Injury
Currently open trials in the same condition.
- NCT07176936 — Improving Speech in Noise Using Noninvasive Stimulation · NA · recruiting
- NCT07473505 — Integrative Bilateral Cervical Sympathetic Blocks for Trauma-Related Symptoms in Special Operations Veterans: A Prospect · recruiting
- NCT07455136 — A Study to Develop a Blood-based Test for Aiding the Diagnosis/Prognosis of Traumatic Brain Injury in Adults and for Mon · recruiting
- NCT07404761 — Safety and Effectiveness of Spatial StimelMD (SSMD) in Subjects With Upper Limb Neuromotor Impairments · NA · recruiting
- NCT07230002 — Effects of Moderate/Severe Traumatic Brain Injury in the Subacute or Chronic Phase on Locomotor Strategies Involved in N · NA · recruiting
Other University Hospital, Clermont-Ferrand trials
Trials by the same sponsor.
- NCT07179276 — Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock · NA · recruiting
- NCT07476768 — PAINDYS_Characterizing Pain in Fibrous Dysplasia of Bone/McCune-Albright Syndrome: an Exploratory Pilot Study · NA · not yet recruiting
- NCT07439146 — Risk of Pneumonia in Intubated Patients in Emergency Situations · not yet recruiting
- NCT07427537 — Exploration of Circulating microRNAs as Biomarkers of Chemo-induced Peripheral Neuropathy: a Study in Cancer Patients · NA · recruiting
- NCT07330856 — Evaluation of Treatments for Dry or Productive Cough · Phase 4 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04543162 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Clermont-Ferrand
- Last refreshed: 8 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04543162.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing