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临床试验/NCT06766435
NCT06766435招募中不适用

Evaluation of the Abbott i-STAT TBI Biomarker Test for Effect on Decreasing CT Utilization Among Adult Emergency Department Patients With Suspected Traumatic Brain Injury

Icahn School of Medicine at Mount Sinai6 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2025年1月30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
450
试验地点
6
主要终点
Number of Head CT scans canceled

研究概览

简要总结

According to the Centers for Disease Control and Prevention, approximately 200,000 hospitalizations occurred in 2020 related to Traumatic Brain Injury (TBI), which does not include many TBIs treated only in emergency departments, urgent care, primary care, or that are not evaluated by a clinician. Head CT is a critical component of care for severe TBI, however in mild TBI there is practice variation with a wider risk to benefit estimation for obtaining head CT imaging. Potential disadvantages of head CT include longer Emergency Department (ED) length of stay (LOS), higher costs, and diagnostic radiation exposure. The i-STAT TBI test is a panel of in vitro diagnostic immunoassays for the quantitative measurements of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in whole blood and a semi-quantitative interpretation of test results derived from these measurements, using the i-STAT Alinity instrument. This biomarker test is cleared for use in adults with mild TBI (Glasgow Coma Scale 13-15) within 24 hours of injury, to aid in determining the need for head CT imaging. Currently, CT head imaging for adults with suspected mild TBI is obtained based on clinicians' usual practice patterns and beliefs about patient expectations. Prior research has demonstrated the blood TBI test may reduce unnecessary CT scans by up to 40%, however the impact on head CT ordering has not yet been studied prospectively. It is important to understand the extent to which a negative TBI biomarker result empowers a clinician to cancel a previously ordered head CT. Given that adult patients with mild TBI often present to EDs, which have access to CT scanners, this is a key setting to assess real-world impact of the i-STAT TBI test on CT head utilization.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

盲法说明

Patient is randomized to the intervention or control arm after consent is obtained. There is no masking for the treatment arm assignment. In the non-notification arm (control arm) participants and care providers will not learn the results of the i-STAT TBI test.

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

  • Age ≥18 years
  • Head injury within 24 hours of research blood collection
  • CT head ordered as part of routine care, not yet completed.
  • Glasgow Coma Scale (GCS) 13 - 15

排除标准

  • Unknown whether head injury occurred, and signs of head injury are absent
  • Previously enrolled in this study in the past 30 days
  • Prisoner or in police custody or known pregnancy
  • Suspected current ischemic or hemorrhagic stroke
  • Suspected open or depressed skull fracture, or signs of skull base fracture
  • History of multiple sclerosis
  • Venipuncture not feasible

结局指标

主要结局

Number of Head CT scans canceled

时间窗: Within 24 hours of Traumatic Brain Injury

Number of head CTs canceled in patients not on anticoagulants as measurement of percentage of reduction in the number of canceled head CTs out of total head CTs ordered (total number and percentage)

次要结局

  • Subset of Number of Head CT scans completed(Within 24 hours of Traumatic Brain Injury)
  • ED Length of Stay(Day 1 after patient ED care visit has ended)
  • Number of cancellations of head CT scan order in patients on anticoagulants(Day 1 after patient ED care visit has ended)
  • Patient Satisfaction Scale(At 14 days after ED visit)
  • Number of head CT scans completed(At 14 days after ED visit)
  • Stress of Uncertainty Scale (SUS)(Day 1 during patient ED care visit)
  • Malpractice Fear Scale (MFS) Scores(Day 1 during patient ED care visit)
  • Whole blood concentrations of GFAP (glial fibrillary acidic protein)(Day 1 during patient ED care visit)
  • Whole blood concentrations of UCH-L1 (ubiquitin C-terminal hydrolase L1)(Day 1 during patient ED care visit)

研究者

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

Shameeke Taylor

Assistant Professor of Emergency Medicine

Icahn School of Medicine at Mount Sinai

研究点 (6)

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