Irreversible Loss of Brain Function (ILBF)DETECT-IVENCT06293170
Automated Screening for Clinically Ascertained Loss of Cerebral Functions
A study testing DETECT and Conventional care in people with Irreversible Loss of Brain Function (ILBF), run by Technische Universität Dresden at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irreversible Loss of Brain Function (ILBF)
- What is being tested?
- DETECT and Conventional care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,800 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2024to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary and/or secondary acute brain damage
- At least 18 years or older
- Necessity of mechanical ventilation
- Deceased upon hospital discharge
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Germany1 site
Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden
Dresden, 01307
Kristian Barlinn, MD, +49 (0)351 458 3565, kristian.barlinn@ukdd.de
About this study
Official title: 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.
Read more
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.
- Being tested
- DETECT, Conventional care
- Keywords
- screening, detection, irreversible loss of brain function, death by neurologic criteria, brain death, organ donation
- Medical subject headings
- Brain Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DETECTOther
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.
Conventional careOther
Conventional care
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Conventional care alone Receives: Other: Conventional care |
| DETECT | Experimental | DETECT in addition to conventional care will be initiated according to randomization plan Receives: Other: DETECT; Other: Conventional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 months
Secondary outcomes (2)
Number of patients who undergo deceased organ donation
The secondary outcome is defined as proportion of patients who undergo deceased organ donation.
Measured: 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.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Irreversible Loss of Brain Function (ILBF)Studies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 4,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristian Barlinn, Technische Universität Dresden
- Investigators
- Kristian Barlinn, MD, Principal investigator, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstraße 74, 01307, Dresden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293170
- Sponsor's protocol ID
- 2024-DETECTIVENEUROLOGYUKD0001
- Acronym
- DETECT-IVE
- Status last verified
- Mar 2024
- First submitted
- 21 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34551858Schoene 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.
PubMed 37626244Schoene 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.
PubMed 41382177
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Screening for Clinically Ascertained Loss of Cerebral Functions in Patients With Severe Brain Damage - an Interventional Cluster Randomized Trial (DETECT-IVE)
- ClinicalTrials.gov ID
- NCT06293170
- Acronym / sponsor ID
- DETECT-IVE / 2024-DETECTIVENEUROLOGYUKD0001
- Keywords
- screening, detection, irreversible loss of brain function, death by neurologic criteria, brain death, organ donation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,800 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Conventional careConventional care alone |
| DETECT | Experimental | Other: DETECT, Other: Conventional careDETECT in addition to conventional care will be initiated according to randomization plan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary and/or secondary acute brain damage
- At least 18 years or older
- Necessity of mechanical ventilation
- Deceased upon hospital discharge
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DETECTDETECT 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. | Other | DETECT |
| Conventional careConventional care | Other | Control, DETECT |
Primary outcome
Number of patients with diagnosis of ILBF
Time frame: 30 months
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.
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Background: PubMed 34551858Trabitzsch 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.
- Background: PubMed 37626244Schoene 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.
- Derived from this study: PubMed 41382177Schoene 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.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristian Barlinn, MD principal investigator
Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstraße 74, 01307, Dresden, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DETECT and Conventional care in people with Irreversible Loss of Brain Function (ILBF), run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristian Barlinn, MD (+49 (0) 351 - 458-3565, kristian.barlinn@ukdd.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with diagnosis of ILBF (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06293170, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.