Biomarkers in Prehospital Rule-out of Intracranial Lesions in TBI Patients (PreTBI I)

University of Aarhus

Status: Completed

Conditions: Traumatic Brain Injury

Treatments: Other: Blood sampling

Study type: Observational

Funder types: Other

Identifiers

NCT02867137

Protokol_v2_270616_PreTBI_I

Details and patient eligibility

About

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.

Enrollment: 595 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients presenting with Glasgow Coma Score (GCS) ≥13-15 and a loss of consciousness for less than 30 min and/or alteration of mental state (being dazed, confused or disorientated) and/or loss of memory for events immediately before and/or after the trauma. The emergency medical service staff will be guided through the inclusion and consent procedures by a simple tablet algorithm.

Exclusion criteria

• Patients <18 years, GCS <13, >6 hours elapsed after trauma, unknown time of trauma, multi trauma, known dementia, chronic psychosis or active central nervous system pathology.

Trial design

595 participants in 1 patient group

Mild TBI patients

Treatment:

Other: Blood sampling