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.
Study Type
OBSERVATIONAL
Enrollment
1,000
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.
Hospital Universitario 12 de Octubre
Madrid, Spain
RECRUITINGBiomarkers 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
Time frame: 24 hours after mild TBI
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.
Time frame: 1 week, 3 months, 6 months and 1 year
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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 months, 6 months and 1 year
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