Blood Biomarkers to Improve Management of Mild Traumatic BRAIN Injury in the Elderly
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mild Traumatic Brain Injury
- Sponsor
- Hospital Universitario 12 de Octubre
- Enrollment
- 2297
- Locations
- 7
- Primary Endpoint
- Biomarkers diagnostic performance
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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.
Investigators
Alfonso Lagares Gómez-Abascal
Department of Neurosurgery, Head
Hospital Universitario 12 de Octubre
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
Outcomes
Primary Outcomes
Biomarkers diagnostic performance
Time Frame: 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 Outcomes
- Determination of the potential of the two biomarkers in predicting neurological symptoms after TBI(1 week and 3 months)
- GFAP reference values(1 Day, day of extraction of the sample)
- UCHL-1 reference values(1 Day, day of extraction of the sample)
- Determination of the potential of the two biomarkers in predicting quality of life assessed by Qolibri-OS after TBI(1 week and 3 months)
- 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)
- Determination of the potential of the two biomarkers in predicting quality of life assessed by EQ-5D-5L after TBI(3 months)
- Determination of the potential of the two biomarkers in depression symptoms assessed by PHQ-9 after TBI(3 months)