S100 Biomarker in the Acute Management of Mild Head Injuries

Completed

• Conditions: Brain Injury; Head Injury

• Registration Number: NCT02650765
• Lead Sponsor: Tampere University Hospital

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

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-12-22
• Study First Submitted QC: 2016-01-07
• Study First Posted: 2016-01-08
• Primary Completion: 2021-02
• Study Completion: 2021-02
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 295

Inclusion Criteria

• Head injury

Exclusion Criteria

• Age under 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Non-contrast head CT	0-72h	Head CT findings: Intracranial traumatic lesions

Secondary Outcome Measures

Name	Time	Method
Rivermead PCS Questionnaire	1 week, 6 months, 1 year, and 2 years	Rivermead PCS Questionnaire
Glasgow Outcome Scale Extended	1 week, 6 months, 1 year, and 2 years	Glasgow Outcome Scale Extended
Modified Rankin Scale	1 week, 6 months, 1 year, and 2 years	Modified Rankin Scale

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland