S100 Biomarker in the Acute Management of Mild Head Injuries

Brain Injury Clinical Trial

— S100  

Official title:

S100 Biomarker in the Acute Management of Mild Head Injuries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02650765
• Other study ID #: R15045
• Status: Completed
• Start date: November 2015
• Est. completion date: February 2021

Study information

• Verified date: October 2021
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 295
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Head injury

Exclusion Criteria:

• Age under 18 years

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Craniocerebral Trauma
• Head Injury
• Wounds and Injuries

Intervention

Other:
• Indications 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.

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (3)

Lead Sponsor	Collaborator
Tampere University Hospital	Harvard Medical School, Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-contrast head CT	Head CT findings: Intracranial traumatic lesions	0-72h
Secondary	Glasgow Outcome Scale Extended	Glasgow Outcome Scale Extended	1 week, 6 months, 1 year, and 2 years
Secondary	Modified Rankin Scale	Modified Rankin Scale	1 week, 6 months, 1 year, and 2 years
Secondary	Rivermead PCS Questionnaire	Rivermead PCS Questionnaire	1 week, 6 months, 1 year, and 2 years