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

University of Aarhus

Status: Completed

Conditions: Traumatic Brain INjury

Treatments: Other: Blood sampling

Study type: Observational

Funder types: Other

Identifiers

NCT03028376

Protokol_v3_240816_PreTBI_II

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

22 participants in 1 patient group

Moderate TBI patients

Description:

GCS 9-13

Treatment:

Other: Blood sampling