Biomarkers in Prehospital Prediction of Need for Neurosurgical Observation or Intervention in TBI Patients

Study Overview
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Brief Summary
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The PreTBI II study aims to investigate the diagnostic potential of prehospital S100B and GFAP measurements in prediction of need for neurosurgical observation and/or intervention in moderate TBI patients, to rule-in high-risk patients. Ultimately to select patients who will benefit from neuro surgical expertise in specialized departments and thereby possibly better patient outcome. Hopefully also minimize treatment delay, secure optimal resource consumption and streamline patient courses by predicting the presence of neurotrauma. Hypotheses: A prehospital serum S100B level > 0,10 microgram/L and expectedly above a certain and currently unknown cut-off value indicates the need for neurosurgical observation and/or intervention in moderate TBI patients. A prehospital serum GFAP level above a certain and currently unknown cut-off value can significantly predict a need for urgent neurosurgical observation and/or intervention in moderate TBI patients. Biomarker dynamics between prehospital and in-hospital biomarker values of S100B and GFAP can significantly predict a need for urgent neurosurgical observation and/or intervention. Biomarker dynamics between prehospital and in-hospital biomarker values of S100B and GFAP can significantly predict hospital course and outcome of patients with moderate TBI.

Official Title
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S100B and Glial Fibrillary Acidic Protein (GFAP) in Prehospital Prediction of Need for Neurosurgical Observation or Intervention in Patients Suffering Moderate Traumatic Brain Injury (TBI)

Conditions
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Traumatic Brain INjury

Intervention / Treatment
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* Other: Blood sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting with Glasgow Coma Score (GCS) GCS 9-13 suffering relevant trauma and displaying relevant clinical indices compatible with TBI as evaluated by EMS staff. Patients are considered incompetent due to on-going alteration of mental state. Exclusion Criteria: Patients <18 years, GCS <9, >6 hours elapsed after trauma, unknown time of trauma, multi trauma, known dementia, chronic psychosis or active central nervous system (CNS) pathology.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Moderate TBI patients<br>GCS 9-13 | Other: Blood sampling<br>* Blood sampling from peripheral venous catheter routinely inserted in trauma patients during transportation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of se-S100B in relation to a binary outcome measured by a yes/no question of need for neurosurgical observation and/or intervention pick yes/no |  | in relation to event within 7 days of trauma | 
| Specificity of se-S100B in relation to a binary outcome measured by a yes/no question of need for neurosurgical observation and/or intervention pick yes/no |  | in relation to event within 7 days of trauma | 
| Positive predictive value of se-S100B in relation to a binary outcome measured by a yes/no question of need for neurosurgical observation and/or intervention pick yes/no |  | in relation to event within 7 days of trauma | 
| Negative predictive value of se-S100B in relation to a binary outcome measured by a yes/no question of need for neurosurgical observation and/or intervention pick yes/no |  | in relation to event within 7 days of trauma | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of se-GFAP in relation to a binary outcome measured by a yes/no question of need for neurosurgical observation and/or intervention pick yes/no |  | in relation to event within 7 days of trauma | 
| Specificity of se-GFAP in relation to a binary outcome measured by a yes/no question of need for neurosurgical observation and/or intervention pick yes/no |  | in relation to event within 7 days of trauma | 
| Positive predictive value of se-GFAP in relation to a binary outcome measured by a yes/no question of need for neurosurgical observation and/or intervention pick yes/no |  | in relation to event within 7 days of trauma | 
| Negative predictive value of se-GFAP in relation to a binary outcome measured by a yes/no question of need for neurosurgical observation and/or intervention pick yes/no |  | in relation to event within 7 days of trauma | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biomarker, point-of-care analysis