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临床试验/NCT03280485
NCT03280485Unknown不适用

Multicenter Validation of the Scandinavian Guidelines for Management of Minimal, Mild and Moderate Head Injury in Adults: a Study Protocol.

Halmstad County Hospital1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2017年9月10日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
3,000
试验地点
1
主要终点
Neurosurgery

研究概览

简要总结

Traumatic brain injuries (TBI) are one of the most common reasons for patients to attend the emergency department (ED). 90% of patients with TBI are defined as mild TBI (mTBI).

A small minority of patients with mTBI would show pathological computed tomography (CT) results and even fewer need neurosurgical intervention. Nevertheless, complications would be so severe, if neurosurgical intervention is delayed, that it has become common practice to subject all patients with mTBI to CT. The high number of CT scans has an impact on health care resources but may also involve risk by subjecting patients through potentially harmful ionizing radiation.

Several independent research groups have attempted to optimize CT use in mTBI patients by forming guidelines that aim to identify patients at high risk for intracranial complications. Most guidelines have been published in the past 15 years and have been validated both prospectively internally and externally; all guidelines have been shown to be safe when implemented in clinical use with few missed complications. However the number of CT scans has not been reduced dramatically, in some cases it has even increased.

In 2013, the new Scandinavian guidelines (SNC13) were published. They are the first guidelines that use a biomarker, S100B, as a tool for managing patients with mTBI. Although S100B has a low specificity for intracranial complications, a high sensitivity makes it suitable to be implemented into clinical practice as a tool for CT reduction. Previous SNC guidelines have been compared to other prominent guidelines with impressive results. The SNC13 have been externally validated in a retrospective study from the USA that was underpowered for important outcomes. Nevertheless, SNC13 have already been partially implemented in clinical practice in Scandinavia. However, a strict multicenter validation has not been performed yet nor a systematic comparison to other available guidelines.

Our primary aim is to validate the performance of the SNC13 in predicting intracranial complications in adult patients presenting with traumatic head injury in Swedish hospitals. A secondary aim is to compare the performance of SNC 13 with 6 other clinical guidelines, with respect to important outcomes. Moreover, to explore the performances of different biomarkers in predicting intracranial complications in predefined subgroups of TBI. Finally, to evaluate the possibility of further improvement of the SNC13.

详细描述

Design Investigators will perform a prospective, multicenter, pragmatic, observational study of adults presenting with traumatic head injury at the ED.

All data necessary for analysis including predictor variables and outcome data for all the seven guidelines included in the study will be registered (table 1). Patients will be managed clinically accordingly to the judgment of the responsible physician and/or local guidelines.

Study setting and population The study will be set in Halmstad, Malmö, Lund, Örebro and Linköping, Sweden. Hallands Hospital Halmstad (HS) is a level II trauma centre, Skåne University Hospital in Malmö and Lund (SUS), Örebro University Hospital, Linköping University Hospital are level I trauma centers.

The coordinating site for the study will be HS where the statistical and the comparative biomarker analysis will be performed.

Inclusion criteria From September 2017 investigators will prospectively enroll all adult patients with a GCS 9-15 that seek the ED within 24h after TBI.

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

入选标准

  • From September 2017 we will prospectively enroll all adult patients with a GCS 9-15 that seek the ED in Halmstad, Malmo, Lund, Linkoping, Orebro (Sweden) within 24h after TBI.
  • Exclusion criteria
  • We will exclude:
  • patients younger than 18 years of age;
  • patients without a Swedish personal identification number due to difficulties in performing the follow up phase;
  • all patients that refuse to participate.

排除标准

  • 未提供

结局指标

主要结局

Neurosurgery

时间窗: 4 years

Need for any neurosurgical proceedure or intervention within 1 week of injury

Intracranial complication

时间窗: 4 years

composite variable of death as consequence of the TBI, need for neurosurgical intervention or marked abnormality on CT

次要结局

  • serious CT findings(4 years)
  • CT findings(4 years)

研究者

发起方
Halmstad County Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Olga Calcagnile

Medical doctor, PhD

Halmstad County Hospital

研究点 (1)

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