Clinical trial NCT02867137: Biomarkers in Prehospital Rule-out of Intracranial Lesions in TBI Patients
Official title: Diagnostic Potential of S100B and GFAP in Prehospital Rule-out of Intracranial Lesions in Patients Suffering Mild Traumatic Brain Injury (TBI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Central Denmark Region
name: Aarhus University Hospital
First posted: 2016-08-15
Enrollment: 595
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients (≥ 18 years) suffering isolated head trauma and receiving an ambulance dispatched by the prehospital emergency medical services in the Central Denmark Region.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity of se-S100B in relation to a binary outcome of clinical patient outcome measured by a yes/no question of "intracranial lesion" pick yes/no
timeFrame: in relation to event within 7 days of trauma
measure: Specificity of se-S100B in relation to a binary outcome of clinical patient outcome measured by a yes/no question of "intracranial lesion" pick yes/no
timeFrame: in relation to event within 7 days of trauma
measure: Positive predictive value of se-S100B in relation to a binary outcome of clinical patient outcome measured by a yes/no question of "intracranial lesion" pick yes/no
timeFrame: in relation to event within 7 days of trauma
measure: Negative predictive value of se-S100B in relation to a binary outcome of clinical patient outcome measured by a yes/no question of "intracranial lesion" pick yes/no
timeFrame: in relation to event within 7 days of trauma
Secondary outcomes:
measure: Sensitivity of se-GFAP in relation to a binary outcome of clinical patient outcome measured by a yes/no question of "intracranial lesion" pick yes/no
timeFrame: in relation to event within 7 days of trauma
measure: Specificity of se-GFAP in relation to a binary outcome of clinical patient outcome measured by a yes/no question of "intracranial lesion" pick yes/no
timeFrame: in relation to event within 7 days of trauma
measure: Positive predictive value of se-GFAP in relation to a binary outcome of clinical patient outcome measured by a yes/no question of "intracranial lesion" pick yes/no
timeFrame: in relation to event within 7 days of trauma
measure: Negative predictive value of se-GFAP in relation to a binary outcome of clinical patient outcome measured by a yes/no question of "intracranial lesion" pick yes/no
timeFrame: in relation to event within 7 days of trauma
Other outcomes:
measure: Biomarker dynamics between prehospital and in-hospital se-S100B in relation to a binary outcome of clinical patient outcome measured by a yes/no question of "intracranial lesion" pick yes/no
timeFrame: in relation to event within 7 days of trauma
measure: Biomarker dynamics between prehospital and in-hospital se-GFAP in relation to a binary outcome of clinical patient outcome measured by a yes/no question of "intracranial lesion" pick yes/no
timeFrame: in relation to event within 7 days of trauma
measure: Biomarker dynamics between prehospital and in-hospital combination of se-S100B andse-GFAP values in relation to a binary outcome of clinical patient outcome measured by a yes/no question of "intracranial lesion" pick yes/no
timeFrame: in relation to event within 7 days of trauma
Locations:
city: Aarhus N
country: Denmark
facility: Prehospital Emergency Medical Services, Central Denmark Region
Study officials:
References:
citation: Seidenfaden SC, Kjerulff JL, Juul N, Kirkegaard H, Moller MF, Munster AB, Botker MT. Diagnostic accuracy of prehospital serum S100B and GFAP in patients with mild traumatic brain injury: a prospective observational multicenter cohort study - "the PreTBI I study". Scand J Trauma Resusc Emerg Med. 2021 Jun 2;29(1):75. doi: 10.1186/s13049-021-00891-5.