Nuevos Biomarcadores y Tecnologia Para Una Mejores Reglas de predicción en el Traumatismo craneoncefálico Leve
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mild Traumatic Brain Injury
- Sponsor
- Hospital Universitario 12 de Octubre
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- Biomarkers diagnostic performance
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Biomarkers diagnostic performance
Time Frame: 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 Outcomes
- 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)
- 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)
- Determination of the potential of the biomarkers in predicting neurological symptoms after TBI(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(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(3 months, 6 months and 1 year)