Clinical trial NCT05425251: BRAINI-2 Elderly Mild TBI European Study
Official title: Blood Biomarkers to Improve Management of Mild Traumatic BRAIN Injury in the Elderly
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mild Traumatic Brain Injury
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
Collaborators: name: Technical University of Munich
name: University Hospital, Grenoble
name: University Hospital, Clermont-Ferrand
name: Hospital Vall d'Hebron
name: BioMérieux
name: EIT Health
First posted: 2022-06-21
Enrollment: 2850
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 2370 participants suffering mild TBI; 480 non TBI participants.

Brief summary: 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.


Eligibility criteria: 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Biomarkers diagnostic performance
timeFrame: 12 hours after mild TBI
Secondary outcomes:
measure: Determination of the potential of the two biomarkers in predicting neurological symptoms after TBI
timeFrame: 1 week and 3 months
measure: GFAP reference values
timeFrame: 1 Day, day of extraction of the sample
measure: UCHL-1 reference values
timeFrame: 1 Day, day of extraction of the sample
measure: Determination of the potential of the two biomarkers in predicting neurological outcome assessed by the Extended Glasgow Outcome Score (GOSE) after TBI
timeFrame: 1 week and 3 months
measure: Determination of the potential of the two biomarkers in predicting quality of life assessed by Qolibri-OS after TBI
timeFrame: 1 week and 3 months
measure: Determination of the potential of the two biomarkers in predicting quality of life assessed by EQ-5D-5L after TBI
timeFrame: 3 months
measure: Determination of the potential of the two biomarkers in depression symptoms assessed by PHQ-9 after TBI
timeFrame: 3 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Grenoble
country: France
facility: CHU Grenoble-Alpes
city: Lyon
country: France
facility: Hôpital Edouard HERRIOT
city: Lyon
country: France
facility: Hôpital Lyon Sud HCL
city: Munich
country: Germany
facility: Klinikum rechts der Isar
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
affiliation: Hospital Universitario 12 de Octubre
name: Alfonso Lagares Gómez-Abascal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: