Automated Screening for Clinically Ascertained Loss of Cerebral Functions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DETECT, Conventional care.
- Who it may be relevant to
- Registry conditions: Irreversible Loss of Brain Function (ILBF). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Automated Screening for Clinically Ascertained Loss of Cerebral Functions in Patients With Severe Brain Damage - an Interventional Cluster Randomized Trial (DETECT-IVE)
Overview
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.
Interventions
- Other 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 - Other Conventional care
Conventional care
Primary outcome measures
- Number of patients with diagnosis of ILBF [Time frame: 30 months]
Secondary outcome measures (2)
- Number of patients who undergo deceased organ donation [Time frame: 30 months]
- Number of patients in whom diagnosis of ILBF was missed [Time frame: 30 months]
Eligibility criteria
Inclusion criteria
- Primary and/or secondary acute brain damage
- At least 18 years or older
- Necessity of mechanical ventilation
- Deceased upon hospital discharge
Exclusion criteria
- none
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Double blind
- Primary purpose
- Screening
Study locations
Germany · 1 center
- Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dres — Dresden
Publications
- 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
Identifiers
NCT: NCT06293170 · 2024-DETECTIVENEUROLOGYUKD0001