Clinical trial NCT02650765: S100 Biomarker in the Acute Management of Mild Head Injuries
Official title: S100 Biomarker in the Acute Management of Mild Head Injuries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injury
Head Injury
Keywords: Brain injury
Head injury
Computed tomography
Emergency department
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
name: Turku University Hospital
First posted: 2016-01-08
Enrollment: 295
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A consecutive sample of adult patients with an acute head injury whom are treated at the emergency department of the Tampere University Hospital, Tampere, Finland

Brief summary: A prospective validation study of the "Scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults". Enrolling a consecutive sample of 1000 adult head injury patients from the emergency department of the Tampere University Hospital (Tampere, Finland). A venous blood sample with S100 analytics (+storage blood) is drawn from every patient. The patients are head CT-scanned according to the SNC guidelines. Outcome assessment (GOSE, MRS, Rivermead PCS Questionnaire) is completed as follows: 1 week, 6 months, 1 year, and 2 years.

Detailed description: A prospective clinical head injury study conducted at the Emergency Department of the Tampere University Hospital, which is situated in Tampere, Finland. The hospital takes care of an catchment area of 524 447 inhabitants both from urban and rural areas. About 100 000 patients are treated in the Emergency department annually.

The study aims to improve the emergency evaluation of patients with an acute head injury, especially a mild head injury. About 80% of head CT scan performed on head injury patients in the Emergency Department of the Tampere University Hospital are negative (= no acute traumatic lesion). There is an urgent need to update the head CT imaging criteria/indications in the context of acute head injury in order to reduce the number of unnecessary scanning. More selective head CT indications result in considerable health care savings and decreased exposure to ionizing radiation, among other benefits.

In this study, the investigators implement the "Scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults" criteria as part of the emergency care of adults head injury patients. By enrolling a large consecutive sample of patients the investigators are validating this new guideline. Emergency department assessment data is combined with long-term outcome parameters and blood-based biomarkers of neurotrauma.

The main aims of the study are:

1. the validation of the Scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults
2. the examination of novel blood-based biomarkers of acute brain injury that correlate with the radiological severity of the injury and the long-term outcome

Eligibility criteria: Inclusion Criteria:

* Head injury

Exclusion Criteria:

* Age under 18 years

Primary outcomes:
measure: Non-contrast head CT
timeFrame: 0-72h
Secondary outcomes:
measure: Glasgow Outcome Scale Extended
timeFrame: 1 week, 6 months, 1 year, and 2 years
measure: Modified Rankin Scale
timeFrame: 1 week, 6 months, 1 year, and 2 years
measure: Rivermead PCS Questionnaire
timeFrame: 1 week, 6 months, 1 year, and 2 years
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Teemu M Luoto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: