BRAINI-2 Elderly Mild TBI European Study

Mild Traumatic Brain Injury Clinical Trial

— BRAINI2ELDER  

Official title:

Blood Biomarkers to Improve Management of Mild Traumatic BRAIN Injury in the Elderly

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05425251
• Other study ID #: HU 12Octubre
• Secondary ID: EIT-HEALTH 22032
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: Hospital Universitario 12 de Octubre
• Contact: Alfonso Lagares Gómez-Abascal, MD, PhD
• Phone: +34917792839
• Email: alfonso.lagares[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2850
• Est. completion date: June 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury

Intervention

Diagnostic Test:
• GFAP and UCH-L1
2x5mL blood samples will be used to determine the performance of the automated VIDAS TBI platform in assessing serum concentrations of GFAP and UCH-L1 to rule out the need for a CT-scan after mTBI.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand
France	CHU Grenoble-Alpes	Grenoble
France	Hôpital Edouard HERRIOT	Lyon
France	Hôpital Lyon Sud HCL	Lyon
Germany	Klinikum rechts der Isar	Munich
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid

Sponsors (7)

Lead Sponsor	Collaborator
Hospital Universitario 12 de Octubre	BioMérieux, EIT Health, Hospital Vall d'Hebron, Technical University of Munich, University Hospital, Clermont-Ferrand, University Hospital, Grenoble

Countries where clinical trial is conducted

France,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers diagnostic performance	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	12 hours after mild TBI
Secondary	Determination of the potential of the two biomarkers in predicting neurological symptoms after TBI	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.	1 week and 3 months
Secondary	GFAP reference values	GFAP serum level distribution in the non-TBI reference population, considering age and comorbidities.	1 Day, day of extraction of the sample
Secondary	UCHL-1 reference values	UCHL-1 serum level distribution in the non-TBI reference population, considering age and comorbidities.	1 Day, day of extraction of the sample
Secondary	Determination of the potential of the two biomarkers in predicting neurological outcome assessed by the Extended Glasgow Outcome Score (GOSE) after TBI	Early and midterm biomarker predictive performance in terms of predicting neurological outcome. Extended Glasgow Outcome Score (GOSE)	1 week and 3 months
Secondary	Determination of the potential of the two biomarkers in predicting quality of life assessed by Qolibri-OS after TBI	Early and midterm biomarker predictive performance in terms of predicting quality of life after mild TBI assessed by Qolibri-OS	1 week and 3 months
Secondary	Determination of the potential of the two biomarkers in predicting quality of life assessed by EQ-5D-5L after TBI	Midterm biomarker predictive performance in terms of predicting quality of life after mild TBI assessed by EQ-5D-5L	3 months
Secondary	Determination of the potential of the two biomarkers in depression symptoms assessed by PHQ-9 after TBI	Midterm biomarker predictive performance in terms of predicting depression symptoms after mild TBI assessed by PHQ-9	3 months