S100 Biomarker in the Acute Management of Mild Head Injuries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 295
- 试验地点
- 1
- 主要终点
- Non-contrast head CT
研究概览
简要总结
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.
详细描述
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:
- the validation of the Scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults
- 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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Head injury
排除标准
- •Age under 18 years
结局指标
主要结局
Non-contrast head CT
时间窗: 0-72h
Head CT findings: Intracranial traumatic lesions
次要结局
- Rivermead PCS Questionnaire(1 week, 6 months, 1 year, and 2 years)
- Glasgow Outcome Scale Extended(1 week, 6 months, 1 year, and 2 years)
- Modified Rankin Scale(1 week, 6 months, 1 year, and 2 years)
研究者
Teemu Luoto
MD, PhD, A/Prof
Tampere University Hospital