Mild Traumatic Brain Injury
Conditions
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.
Interventions
OTHERSerum and saliva biomarkers
2x5mL blood samples and saliva samples will be used to determine the performance of different blood based and saliva biomarkers for determining diagnostic management and prognosis in mTBI patients.
Sponsors
Hospital Universitario 12 de Octubre
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
Countries
Spain
Contacts
Primary ContactAlfonso Lagares, MD, PhD
Outcome results
None listed