Automated Screening for Clinically Ascertained Loss of Ce... | NCT06293170

NCT06293170

Protocol Section

Identification Module

Results Section

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No data is available for this block.

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

Contacts/Locations Module

Name	Role	Phone	Extension	Email
Kristian Barlinn, MD	Contact	+49 (0) 351 - 458-3565		kristian.barlinn@ukdd.de

Overall Officials

Name	Affiliation	Role
Kristian Barlinn, MD	Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstraße 74, 01307, Dresden, Germany	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden		Dresden		01307	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34551858	Background	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.
37626244	Background

Label	URL
Related Info	View source

Condition Browse Module

ID	Term
D001926	Brain Death

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D003128	Coma

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.