Automated Screening for Clinically Ascertained Loss of Cerebral Functions

NCT06293170 | Not Yet Recruiting

• 1 other identifier: 2024-DETECTIVENEUROLOGYUKD0001
• Study Type: interventional
• Target: 4,800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Irreversible Loss of Brain Function (ILBF)

Keywords

screening; detection; irreversible loss of brain function; death by neurologic criteria; brain death; organ donation

Outcome Measures

Primary Outcomes (1)

• Number of patients with diagnosis of ILBF

  The primary outcome is defined as proportion of patients with an eventual diagnosis of ILBF in accordance with the guidelines of the German Medical Association during hospitalization.

  30 months

Secondary Outcomes (2)

• Number of patients who undergo deceased organ donation

  30 months

• Number of patients in whom diagnosis of ILBF was missed

  30 months

Study Arms (2)

Control

OTHER

Conventional care alone

Other: Conventional care

DETECT

EXPERIMENTAL

DETECT in addition to conventional care will be initiated according to randomization plan

Other: DETECT; Other: Conventional care

Interventions

DETECT OTHER

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.

DETECT

Conventional care OTHER

Conventional care

Control; DETECT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden

Dresden, 01307, Germany

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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. doi: 10.1186/s13063-025-09354-z. Online ahead of print.

  PMID: 41382177 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Brain Death

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coma; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristian Barlinn, MD

  Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstraße 74, 01307, Dresden, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristian Barlinn, MD

CONTACT

+49 (0) 351 - 458-3565; kristian.barlinn@ukdd.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 5, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

DE (1)