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S100 Biomarker in the Acute Management of Mild Head Injuries

S100 Biomarker in the Acute Management of Mild Head Injuries

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02650765
Acronym
S100
Enrollment
295
Registered
2016-01-08
Start date
2015-11-30
Completion date
2021-02-28
Last updated
2021-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injury, Head Injury

Keywords

Brain injury, Head injury, Computed tomography, Emergency department

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

Interventions

OTHERIndications for head CT imaging after acute head injury

Indications for head CT imaging after acute head injury as per the Scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults.

Sponsors

Harvard Medical School (HMS and HSDM)
CollaboratorOTHER
Turku University Hospital
CollaboratorOTHER_GOV
Tampere University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Head injury

Exclusion criteria

* Age under 18 years

Design outcomes

Primary

MeasureTime frameDescription
Non-contrast head CT0-72hHead CT findings: Intracranial traumatic lesions

Secondary

MeasureTime frameDescription
Glasgow Outcome Scale Extended1 week, 6 months, 1 year, and 2 yearsGlasgow Outcome Scale Extended
Modified Rankin Scale1 week, 6 months, 1 year, and 2 yearsModified Rankin Scale
Rivermead PCS Questionnaire1 week, 6 months, 1 year, and 2 yearsRivermead PCS Questionnaire

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026