Informations générales (source: ClinicalTrials.gov)
Blood Biomarkers to Improve Management of Mild Traumatic BRAIN Injury in the Elderly (BRAINI2ELDER)
Observational
Hospital Universitario 12 de Octubre (Voir sur ClinicalTrials)
mars 2022
mars 2025
03 octobre 2024
Mild traumatic brain injury (mTBI) is one of the most frequent emergencies in the elderly
population. Despite most mTBI are managed with cranial computed tomography (CT), only 10%
of CTs show lesions, determining CT overuse. The use of serum glial fibrillary acidic
protein (GFAP) and Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) have shown potential for
ruling out the need for cranial CT. However evidence on biomarker use in mild TBI were
not based on studies that included aged participants and patients with comorbidities for
which biomarker levels could vary. This is why there is a need for a prospective study
that assesses the predictive performance of these two biomarkers in the elderly
population, both in elderly patients suffering mild TBI and in a reference population,
including patients and participants with and without comorbidities.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Clermont-Ferrand - Clermont-Ferrand - France | Vincent Sapin, PhD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Grenoble-Alpes - Grenoble - France | Damien VIGNLINO, MD, PhD | Contact (sur clinicalTrials) | |||
| Hôpital Edouard HERRIOT - Lyon - France | Laurent JACQUIN, MD, PhD | Contact (sur clinicalTrials) | |||
| Hôpital Lyon Sud HCL - Lyon - France | Marion DOUPLAT, MD, PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- BRAINI2-ELDERLY DIAGNOSTIC & PROGNOSTIC:
- Patients ≥65 years of age
- Mild TBI (GCS 13-15 on admission) with indication of brain CT scan in the 12
hours after injury ;
- Blood sample obtained ≤12 h after injury and CT scan preferably ≤6h from blood
sample.
- BRAINI2-ELDERLY REFERENCE:
- Non TBI patients ≥65 years of age
- BRAINI2-ELDERLY DIAGNOSTIC & PROGNOSTIC:
- Patients ≥65 years of age
- Mild TBI (GCS 13-15 on admission) with indication of brain CT scan in the 12
hours after injury ;
- Blood sample obtained ≤12 h after injury and CT scan preferably ≤6h from blood
sample.
- BRAINI2-ELDERLY REFERENCE:
- Non TBI patients ≥65 years of age
- BRAINI2-ELDERLY DIAGNOSTIC & PROGNOSTIC:
- Age below 65 years.
- 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 from the trauma scene or prehospital
management.
- Venipuncture not feasible
- No realization of brain CT-scan
- Subject under judiciary control
- Subject in inclusion period of a drug interventional study
- BRAINI2-ELDERLY REFERENCE:
- Subject in inclusion period of another drug interventional study
- Patients harboring a brain tumor
- Patients that have had a stroke or neurosurgical operation 1 month prior to the
inclusion in the study.