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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MILD TBI Diagnostic and long term prognostic study | 1000 patients suffering mild Traumatic Brain Injury |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serum and saliva biomarkers | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers diagnostic performance | 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 | 24 hours after mild TBI |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the potential of the biomarkers in predicting neurological symptoms after TBI | 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. | 1 week, 3 months, 6 months and 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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1000 participants suffering mild TBI
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alfonso Lagares, MD, PhD | Contact | +34917792839 | alfonso.lagares@salud.madrid.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Serum, saliva
| Determination of the potential of the biomarkers in predicting neurological outcome assessed by the Extended Glasgow Outcome Score (GOSE) after TBI | Early, midterm and long term biomarker predictive performance in terms of predicting neurological outcome. Extended Glasgow Outcome Score (GOSE) | 1 week, 3 months, 6 months and 1 year |
| Determination of the potential of the biomarkers in predicting quality of life assessed by Qolibri-OS after TBI | Early, midterm and longterm biomarker predictive performance in terms of predicting quality of life after mild TBI assessed by Qolibri-OS | 1 week, 3 months, 6 months and 1 year |
| Determination of the potential of the biomarkers in predicting quality of life assessed by EQ-5D-5L after TBI | Mid and longterm biomarker predictive performance in terms of predicting quality of life after mild TBI assessed by EQ-5D-5L | 3 months, 6 months and 1 year |
| Determination of the potential of the biomarkers in predicting quality of sleep assessed by the Epworth and Pittsburgh Scales | Mid and longterm biomarker predictive performance in terms of quality of sleep | 3 months, 6 months and 1 year |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |