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NCT Number: NCT02650765

S100 Biomarker in the Acute Management of Mild Head Injuries

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tampere University Hospital

Tampere, 33521, Finland

About this study

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:

  • the validation of the Scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Head injury

Exclusion criteria

  • Age under 18 years

Treatment and study plan

Indications for head CT imaging after acute head injury

Other

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.

Primary outcomes

  1. Non-contrast head CT

    Time frame: 0-72h

    Head CT findings: Intracranial traumatic lesions

Secondary outcomes

  1. Glasgow Outcome Scale Extended

    Time frame: 1 week, 6 months, 1 year, and 2 years

    Glasgow Outcome Scale Extended

  2. Modified Rankin Scale

    Time frame: 1 week, 6 months, 1 year, and 2 years

    Modified Rankin Scale

  3. Rivermead PCS Questionnaire

    Time frame: 1 week, 6 months, 1 year, and 2 years

    Rivermead PCS Questionnaire

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Harvard Medical School (HMS and HSDM)
  • Turku University Hospital

Registry information

Acronym: S100

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Jan 8, 2016
Registry last updated
Oct 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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