S100 Biomarker in the Acute Management of Mild Head Injuries

Status Completed

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02650765
Study type	Observational
Source	Tampere University Hospital
Contact
Status	Completed
Phase
Start date	November 2015
Completion date	February 2021

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02710123` - Sub-Threshold Exercise Treatment for Adolescents With Sports Related Concussion	N/A
Recruiting	`NCT02777060` - Exploring the Effectiveness of Sensor-based Balance Training on Patient Outcome Measures	N/A
Completed	`NCT02262286` - MIND (Management of Traumatic Brain Injury Diagnosis)	N/A
Completed	`NCT01461902` - Vasospasm in Pediatric Traumatic Brain Injury	N/A
Recruiting	`NCT01198964` - Optimization of Human Cortical Stimulation
Active, not recruiting	`NCT01207050` - Effect of Rozerem on Sleep Among People With Traumatic Brain Injury	Phase 4
Completed	`NCT00875329` - Traumatic Brain Injury (TBI) Screening Instruments	N/A
Completed	`NCT01201863` - Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy	Phase 4
Completed	`NCT01035606` - Training in Goal-directed Attention Regulation for Individuals With Brain Injury	N/A
Completed	`NCT01059890` - Cerebral Antibiotics Distribution After Acute Brain Injury	Phase 1
Completed	`NCT00571623` - Automated Chest Physiotherapy to Improve Outcomes in Neuro	N/A
Completed	`NCT00596765` - Neuropsychological Cognitive Behavioral Therapy for Patients With Acquired Brain Injury	N/A
Completed	`NCT00336466` - The Erythropoietin NeuroProtective Effect: Assessment in CABG Surgery (TENPEAKS)	Phase 2
Recruiting	`NCT05105763` - Biofeedback Gait Retraining for Stiff Knee Gait Correction	N/A
Recruiting	`NCT02495558` - Cough Assessment in Patients With Severe Acquired Brain Injury	N/A
Completed	`NCT02100592` - Early Verticalization in neuroICU With ERIGO: a Safety and Feasibility Study	Phase 1/Phase 2
Completed	`NCT00797680` - Duration of Hypothermia for Neuroprotection After Pediatric Cardiac Arrest	Phase 2
Completed	`NCT00018499` - Genotype Influence on Recovery After Traumatic Brain Injury	N/A
Recruiting	`NCT02567201` - Electrophysiological Evaluation of Voluntary Attention	N/A
Withdrawn	`NCT05581927` - Whole-Body Hypothermia for Neonates With Hypoxic-Ischemic Encephalopathy(HIE)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

S100 Biomarker in the Acute Management of Mild Head Injuries — S100

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms