Automated Screening for Clinically Ascertained Loss of Cerebral Functions (DETECT-IVE)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Irreversible Loss of Brain Function (ILBF)
• Intervention / Treatment: Other: Conventional care; Other: DETECT

• Study Type: Interventional
• Enrollment (Estimated): 4800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristian Barlinn, MD; Phone Number: +49 (0) 351 - 458-3565; Email: kristian.barlinn@ukdd.de

Study Locations

• Germany
  • Dresden, Germany, 01307
    • Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden
    • Contact: Kristian Barlinn, MD; Phone Number: +49 (0)351 458 3565; Email: kristian.barlinn@ukdd.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control; Conventional care alone	Other: Conventional care; Conventional care
Experimental: DETECT; DETECT in addition to conventional care will be initiated according to randomization plan	Other: Conventional care; Conventional care; 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients who undergo deceased organ donation	The secondary outcome is defined as proportion of patients who undergo deceased organ donation.	30 months
Number of patients in whom diagnosis of ILBF was missed	The secondary outcome is defined as the failure to identify potential cases of ILBF. This outcome measure will be determined through retrospective evaluation of all deceased cases who were not diagnosed with ILBF during hospitalization. For this purpose, independent neurointensivists will review computed tomography and/or magnetic resonance imaging scans for findings indicative of critical intracranial pressure such as severe hypoxic cerebral edema, intracerebral hemorrhage with intraventricular extension or space-occupying hemispheric infarction, in addition to clinical information. The final decision regarding the potential development of ILBF will be based on consensus between two neurointensivists.	30 months

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Investigators: Principal Investigator: Kristian Barlinn, MD, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstraße 74, 01307, Dresden, Germany

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: March 1, 2024
• First Posted (Estimated): March 5, 2024

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: organ donation; screening; brain death; detection; irreversible loss of brain function; death by neurologic criteria
• Other Study ID Numbers: 2024-DETECTIVENEUROLOGYUKD0001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No