S100 Biomarker in the Acute Management of Mild Head Injuries (S100)

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.

Study Overview

• Status: Completed
• Conditions: Brain Injury; Head Injury
• Intervention / Treatment: Other: Indications for head CT imaging after acute head injury

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

• Study Type: Observational
• Enrollment (Actual): 295

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland, 33521
    • Tampere university Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

• Head injury

Exclusion Criteria:

• Age under 18 years

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-contrast head CT	Head CT findings: Intracranial traumatic lesions	0-72h

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glasgow Outcome Scale Extended	Glasgow Outcome Scale Extended	1 week, 6 months, 1 year, and 2 years
Modified Rankin Scale	Modified Rankin Scale	1 week, 6 months, 1 year, and 2 years
Rivermead PCS Questionnaire	Rivermead PCS Questionnaire	1 week, 6 months, 1 year, and 2 years

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: Harvard Medical School (HMS and HSDM); Turku University Hospital
• Investigators: Principal Investigator: Teemu M Luoto, MD, PhD, Tampere university Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: December 22, 2015
• First Submitted That Met QC Criteria: January 7, 2016
• First Posted (Estimate): January 8, 2016

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Computed tomography; Emergency department; Brain injury; Head injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Craniocerebral Trauma
• Other Study ID Numbers: R15045