BRAINI-2 Elderly Mild TBI European Study

Recruiting

• Conditions: Mild Traumatic Brain Injury
• Interventions: Diagnostic Test: GFAP and UCH-L1

• Registration Number: NCT05425251
• Lead Sponsor: Hospital Universitario 12 de Octubre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2022-03-11
• Study First Submitted QC: 2022-06-15
• Study First Posted: 2022-06-21
• Status Verified: 2023-10
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2850

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BRAINI2-ELDERLY DIAGNOSTIC & PROGNOSTIC	GFAP and UCH-L1	2370 patients suffering mild Traumatic brain injury
BRAINI2-ELDERLY REFERENCE	GFAP and UCH-L1	480 non-tbi elderly reference patients

Primary Outcome Measures

Name	Time	Method
Biomarkers diagnostic performance	12 hours after mild TBI	Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of GFAP and UCHL-1 used separately and in combination to detect the presence or absence of intracranial lesions on CT scan

Secondary Outcome Measures

Name	Time	Method
Determination of the potential of the two biomarkers in predicting neurological symptoms after TBI	1 week and 3 months	Early and midterm biomarker predictive performance in terms of predicting neurological outcome. Neurological status at 1 week and 3 months after TBI and Rivermead post concussion questionnaire.
GFAP reference values	1 Day, day of extraction of the sample	GFAP serum level distribution in the non-TBI reference population, considering age and comorbidities.
UCHL-1 reference values	1 Day, day of extraction of the sample	UCHL-1 serum level distribution in the non-TBI reference population, considering age and comorbidities.
Determination of the potential of the two biomarkers in predicting quality of life assessed by Qolibri-OS after TBI	1 week and 3 months	Early and midterm biomarker predictive performance in terms of predicting quality of life after mild TBI assessed by Qolibri-OS
Determination of the potential of the two biomarkers in predicting neurological outcome assessed by the Extended Glasgow Outcome Score (GOSE) after TBI	1 week and 3 months	Early and midterm biomarker predictive performance in terms of predicting neurological outcome. Extended Glasgow Outcome Score (GOSE)
Determination of the potential of the two biomarkers in predicting quality of life assessed by EQ-5D-5L after TBI	3 months	Midterm biomarker predictive performance in terms of predicting quality of life after mild TBI assessed by EQ-5D-5L
Determination of the potential of the two biomarkers in depression symptoms assessed by PHQ-9 after TBI	3 months	Midterm biomarker predictive performance in terms of predicting depression symptoms after mild TBI assessed by PHQ-9

Trial Locations

Locations (7)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CHU Grenoble-Alpes; 🇫🇷 Grenoble, France

Hôpital Edouard HERRIOT; 🇫🇷 Lyon, France

Hôpital Lyon Sud HCL; 🇫🇷 Lyon, France

Klinikum rechts der Isar; 🇩🇪 Munich, Germany

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain