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Идёт набор NCT06766435

Evaluation of the Abbott i-STAT TBI Biomarker Test

Без фазы С лечением Traumatic Brain Injury

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: i-STAT TBI Test.
Кому может быть актуально
Состояния в реестре: Traumatic Brain Injury. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

  • Устройство i-STAT TBI Test
    The Abbott i-STAT TBI test result is shared with the enrolled patient and treating clinicians.

Первичные конечные точки

  • Number of Head CT scans canceled [Срок оценки: Within 24 hours of Traumatic Brain Injury]
Вторичные конечные точки (9)
  • Subset of Number of Head CT scans completed [Срок оценки: Within 24 hours of Traumatic Brain Injury]
  • ED Length of Stay [Срок оценки: Day 1 after patient ED care visit has ended]
  • Number of cancellations of head CT scan order in patients on anticoagulants [Срок оценки: Day 1 after patient ED care visit has ended]
  • Patient Satisfaction Scale [Срок оценки: At 14 days after ED visit]
  • Number of head CT scans completed [Срок оценки: At 14 days after ED visit]
  • Stress of Uncertainty Scale (SUS) [Срок оценки: Day 1 during patient ED care visit]
  • Malpractice Fear Scale (MFS) Scores [Срок оценки: Day 1 during patient ED care visit]
  • Whole blood concentrations of GFAP (glial fibrillary acidic protein) [Срок оценки: Day 1 during patient ED care visit]
  • Whole blood concentrations of UCH-L1 (ubiquitin C-terminal hydrolase L1) [Срок оценки: Day 1 during patient ED care visit]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

США · 3 центра
  • Mount Sinai Morningside — New York
  • Mount Sinai Hospital — New York
  • Mount Sinai West — New York

Идентификаторы

NCT: NCT06766435 · STUDY-24-01057 · CRS-2024-001-257

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗