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临床试验/NCT04995068
NCT04995068招募中不适用

Stockholm Score of Lesion Development on Computerized Tomography Following Mild Traumatic Brain Injury

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 20,000 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20,000
试验地点
1
主要终点
Traumatic intracranial lesion

研究概览

简要总结

Mild traumatic brain injury (mTBI) is one of the most common reasons behind emergency department (ED) visits. A small portion of mTBI patients will develop an intracranial lesion that might require neurosurgical intervention. Several guidelines have been developed to help direct these patients for head Computerized Tomography (CT) scanning, but they lack specificity, mainly focus on ruling out lesions, and do not estimate the risk of lesion development. The aim of this retrospective observational study is to create a risk stratification score that predicts the likelihood of intracranial lesion development, lesion progression, and need for neurosurgical management in patients with mTBI presenting to the ED. Eligible patients are adults (≥ 15 years) with mTBI (defined as admission Glasgow Coma Scale (GCS) 13-15) who presented to the ED within 24 hours of injury to any ED in Stockholm, Sweden between 2010-2020. Reasons for ED visit and Internal Classification of Disease (ICD) codes will be used to screen for patients. Machine-learning models will be applied. The primary outcome will be a traumatic lesion on head CT, defined as a cerebral contusion, subdural haematoma, epidural haematoma, subarachnoid haemorrhage, intraventricular haemorrhage, diffuse axonal injury, skull fracture, traumatic infarction or sinus thrombosis. The secondary outcomes will be any clinically significant lesion, defined as an intracranial finding that led to neurosurgical intervention, discontinuation or reversal of anticoagulant or antiplatelet medication, hospital admission > 48 hours due to the TBI, or death.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (≥ 15 years)
  • Presented to emergency department within 24 hours of TBI
  • GCS 13-15 at presentation to the emergency department

排除标准

  • No CT scan performed
  • Patient from another Region in Sweden/another country
  • Penetrating TBI
  • Secondary transfer from other emergency department
  • Medical record missing

结局指标

主要结局

Traumatic intracranial lesion

时间窗: Immediately after the procedure (CT-scan)

Any traumatic lesion on head CT, defined as a cerebral contusion, subdural haematoma, epidural haematoma, subarachnoid haemorrhage, intraventricular haemorrhage, diffuse axonal injury, skull fracture, traumatic infarction or sinus thrombosis.

次要结局

  • Clinically significant traumatic intracranial lesion(Immediately after the procedure (CT-scan))
  • Lesion progression(Within 48 hours of the first CT-scan)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eric Thelin

Principle Investigator

Karolinska Institutet

研究点 (1)

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