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Biomarkers in Prehospital Rule-out of Intracranial Lesions in TBI Patients

NCT02867137 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 595

Last updated 2019-04-24

No results posted yet for this study

Summary

The PreTBI I study will investigate whether prehospital blood samples drawn already in the ambulance can rule-out intracranial lesions in patients suffering head trauma. The study aims to improve triage and treatment of patients suffering mild head trauma, who are considered low-risk patients. These patients do not always benefit from hospitalization, but are nevertheless admitted on precaution, as clinical assesment can be difficult.

Hypotheses:

1. A prehospital measurement of serum S100B ≤ 0,10 microgram/L in mild TBI patients rules out traumatic intracranial lesion with a sensitivity \>97%.
2. A prehospital measurement of serum GFAP (glial acidic fibrillary protein) in mild TBI patients rules out traumatic intracranial lesion with sensitivity \>97% and results in lower false positive rate than S100B.
3. Prehospital measurements of both GFAP and S100B results in lower false positive rates than in-hospital measurements.

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 NCT02867137 on ClinicalTrials.gov