New Protein Biomarkers and Technology for Improving Diagnosis and Outcome Prediction in Mild TBI

Recruiting

• Conditions: Mild Traumatic Brain Injury
• Interventions: Other: Serum and saliva biomarkers

• Registration Number: NCT06327776
• Lead Sponsor: Hospital Universitario 12 de Octubre

Brief Summary

Mild traumatic brain injury(mTBI) is a common cause of consultation to the emergency rooms worldwide and is the most common form of traumatic brain injury. Though classified as mild, as many as 40% of patients suffering mTBI do not make complete recoveries or present persistent symptoms. The present study is intended to determine long term outcome of patients suffering mTBI and to establish new prognostic models with the use of serum and saliva based biomarkers. For this purpose this study will not exclude patients regarding their comorbidities.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-04
• Status Verified: 2023-10
• Study First Submitted: 2024-03-18
• Study First Submitted QC: 2024-03-18
• Last Update Submitted: 2024-03-18
• Study First Posted: 2024-03-25
• Last Update Posted: 2024-03-25
• Primary Completion: 2025-07-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Mild TBI (GCS 13-15 on admission)
• Blood sample obtained ≤24h after injury

Exclusion Criteria

• GCS 3-12 on admission
• Time of injury unknown
• Time to injury exceeding 24 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
• Subject under judiciary control

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MILD TBI Diagnostic and long term prognostic study	Serum and saliva biomarkers	1000 patients suffering mild Traumatic Brain Injury

Primary Outcome Measures

Name	Time	Method
Biomarkers diagnostic performance	24 hours after mild TBI	Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of GFAP and UCHL-1, S100B, Osteopontin, SAA1, YKL-40, Copeptin, NSE, C reactive protein, procalcitonin to detect the presence or absence of intracranial lesions on CT scan

Secondary Outcome Measures

Name	Time	Method
Determination of the potential of the biomarkers in predicting neurological outcome assessed by the Extended Glasgow Outcome Score (GOSE) after TBI	1 week, 3 months, 6 months and 1 year	Early, midterm and long term biomarker predictive performance in terms of predicting neurological outcome. Extended Glasgow Outcome Score (GOSE)
Determination of the potential of the biomarkers in predicting quality of sleep assessed by the Epworth and Pittsburgh Scales	3 months, 6 months and 1 year	Mid and longterm biomarker predictive performance in terms of quality of sleep
Determination of the potential of the biomarkers in predicting neurological symptoms after TBI	1 week, 3 months, 6 months and 1 year	Early and midterm biomarker predictive performance in terms of predicting neurological outcome. Neurological status at 1 week, 3 months, 6 months and 1 year after TBI and Rivermead post concussion questionnaire.
Determination of the potential of the biomarkers in predicting quality of life assessed by Qolibri-OS after TBI	1 week, 3 months, 6 months and 1 year	Early, midterm and longterm biomarker predictive performance in terms of predicting quality of life after mild TBI assessed by Qolibri-OS
Determination of the potential of the biomarkers in predicting quality of life assessed by EQ-5D-5L after TBI	3 months, 6 months and 1 year	Mid and longterm biomarker predictive performance in terms of predicting quality of life after mild TBI assessed by EQ-5D-5L

Trial Locations

Locations (1)

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain