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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

595 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-15

Study Completion Date

2019-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT03028376

Traumatic Brain INjury

COMPLETED

Prognostic Potential of Prehospital Biomarkers in TBI Patients

NCT03062566

Traumatic Brain INjury

COMPLETED

A Study of Biomarkers of Mild Traumatic BRAIN Injury

NCT04032509

Mild Traumatic Brain Injury

COMPLETED

Biomarkers of Brain Injury: Magnitude and Outcome of Mild and Moderate TBI

NCT01786447

Brain Injuries, Traumatic

TERMINATED

Transforming Research and Clinical Knowledge in Traumatic Brain Injury

NCT02119182

Traumatic Brain Injury

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Traumatic Brain Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mild TBI patients

Blood sampling

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blood sampling

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No