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

Traumatic Brain INjury Clinical Trial

Official title:
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)

Clinical Trial Summary

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:

1. 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.

2. 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.

3. 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.

4. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03028376
Study type Observational
Source University of Aarhus
Contact
Status Completed
Phase
Start date February 15, 2017
Completion date February 1, 2019
View Details
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