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

NCT03028376 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 22

Last updated 2019-04-24

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Blood sampling

Blood sampling from peripheral venous catheter routinely inserted in trauma patients during transportation

Sponsors & Collaborators

  • Central Denmark Region

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-15
Primary Completion
2019-02-01
Completion
2019-02-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03028376 on ClinicalTrials.gov