S100 Biomarker in the Acute Management of Mild Head Injuries

NCT ID: NCT02650765

Last Updated: 2021-10-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 295 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2021-02-28

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

Conditions

Brain Injury; Head Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Head injury

Exclusion Criteria

• Age under 18 years

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role: collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role: collaborator

Tampere University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Teemu Luoto

MD, PhD, A/Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Teemu M Luoto, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

Tampere University Hospital

Tampere, , Finland

Countries

Finland

Other Identifiers

R15045

Identifier Type: -

Identifier Source: org_study_id