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Набор скоро начнётся NCT06293170

Automated Screening for Clinically Ascertained Loss of Cerebral Functions

Без фазы С лечением Irreversible Loss of Brain Function (ILBF)

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: DETECT, Conventional care.
Кому может быть актуально
Состояния в реестре: Irreversible Loss of Brain Function (ILBF). 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
Германия
Следующий шаг
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Официальное название

Automated Screening for Clinically Ascertained Loss of Cerebral Functions in Patients With Severe Brain Damage - an Interventional Cluster Randomized Trial (DETECT-IVE)

Обзор

Rationale: The low organ donation rate in Germany is associated with the inadequate identification of patients at risk of developing irreversible loss of brain function (ILBF; i.e. brain death). An automated digital screening tool, DETECT (AutomateD ScrEening for Clinically AscerTainEd Loss of Cerebral FuncTions in Patients with Severe Brain Damage), has been developed to prospectively identify intensive care patients who are at risk of developing ILBF. Objective: The objective of the study is to evaluate the effectiveness of an automated digital screening tool in the identification of patients with severe brain damage who are at risk of impending ILBF compared to standard practice without digital support. Study design: Stepped-Wedge, multicenter, cluster-randomized, controlled trial Study population: The study includes patients aged 18 years or older with primary and/or secondary acute brain damage, requiring mechanical ventilation, and who are deceased upon hospital discharge. Intervention: DETECT periodically processes real-time data from the corresponding electronic medical record system to screen for a combination of coma, indicated by a Richmond Agitation Sedation Scale (RASS) score of - 4 or - 5 or Glasgow Coma Scale (GCS) score of 6-3, along with manually assessed absence of bilateral pupillary light reflexes. Both findings are considered early indicators of impending ILBF. In case of positive screening results, an automated notification will be sent via the hospital's email server to the corresponding transplant coordinators and intensivists. The email sent aims to prompt clinical assessment of the reported patient and, if necessary, initiate a guideline-based ILBF examination. Primary study endpoint: The primary endpoint is the identification of patients who eventually develop ILBF during hospitalization. Secondary study endpoints: Secondary outcomes encompass the missed identification of potential ILBF cases (as retrospectively classified) and the rate of deceased organ donations. Upon completion of the study, a survey will be conducted to investigate the stakeholders' experiences with DETECT.

Вмешательства

  • Другое DETECT
    DETECT periodically processes real-time data from the corresponding electronic medical record system to screen for a combination of coma, indicated by a Richmond Agitation Sedation Scale (RASS) score of - 4 or - 5 or Glasgow Coma Scale (GCS) score of 6-3, along with manually assessed absence of bilateral pupillary light reflexes. Both findings are considered early indicators of impending ILBF. In case of positive screening results, an automated notification will be sent via the hospital's email
  • Другое Conventional care
    Conventional care

Первичные конечные точки

  • Number of patients with diagnosis of ILBF [Срок оценки: 30 months]
Вторичные конечные точки (2)
  • Number of patients who undergo deceased organ donation [Срок оценки: 30 months]
  • Number of patients in whom diagnosis of ILBF was missed [Срок оценки: 30 months]

Критерии участия

Критерии включения

  • Primary and/or secondary acute brain damage
  • At least 18 years or older
  • Necessity of mechanical ventilation
  • Deceased upon hospital discharge

Критерии исключения

  • none

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Последовательный дизайн
Маскирование
Двойное слепое
Основная цель
Скрининг

Центры проведения

Германия · 1 центр
  • Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dres — Dresden

Публикации

  • Trabitzsch A, Pleul K, Barlinn K, Franz V, Dengl M, Gotze M, Guldner A, Eberlein-Gonska M, Albrecht DM, Hugo C. An Automated Electronic Screening Tool (DETECT) for the Detection of Potentially Irreversible Loss of Brain Function. Dtsch Arztebl Int. 2021 Oct 15;118(41):683-690. doi: 10.3238/arztebl.m2021.0307. PMID 34551858
  • Schoene D, Freigang N, Trabitzsch A, Pleul K, Kaiser DPO, Roessler M, Winzer S, Hugo C, Gunther A, Puetz V, Barlinn K. Identification of patients at high risk for brain death using an automated digital screening tool: a prospective diagnostic accuracy study. J Neurol. 2023 Dec;270(12):5935-5944. doi: 10.1007/s00415-023-11938-1. Epub 2023 Aug 25. PMID 37626244
  • Schoene D, Roessler M, Pleul K, Hoehne S, Trabitzsch A, Barnett D, Guenzel A, Huttner HB, Sedlmayr M, Gunther A, Barlinn K; DETECT-IVE Investigators. Automated screening for clinically ascertained loss of cerebral functions in patients with severe brain injury-study protocol for a cluster-randomized interventional trial. Trials. 2025 Dec 11;27(1):39. doi: 10.1186/s13063-025-09354-z. PMID 41382177

Идентификаторы

NCT: NCT06293170 · 2024-DETECTIVENEUROLOGYUKD0001

Первоисточники (государственные реестры)

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