Confirming Permanent Lack of Blood Flow to the Brain During A-NRP DCC Organ Transplant

Organ Transplant Clinical Trial

— CONCLUDE  

Official title:

Confirming the Permanent Cessation of Intracranial Circulation During Abdominal Normothermic Regional Perfusion After the Determination of Death by Circulatory Criteria

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05884736
• Other study ID #: 4436
• Status: Recruiting
• Start date: April 2, 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Western University, Canada
• Contact: Crystal Engelage, PhD
• Phone: 519-685-8500
• Email: Crystal.Engelage[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to evaluate the surgical technique used in Abdominal Normothermic Regional Perfusion (A-NRP) in death determination by circulatory criteria (DCC) organ donors. The proposed study will demonstrate that there is no resumption of brain blood flow or activity during the A-NRP procedure. This will be assessed using multimodal neuromonitoring protocol that enables continuous focused monitoring of brain blood flow and activity during A-NRP. This will provide evidence that brain blood flow and activity does not resume during NRP and ensure donor safety in using this technique in standard of care practice.

Description:

This will be a multi-centre prospective observational cohort study that will enroll eligible DCC donors at participating donation hospitals. Participating programs will implement the A-NRP processes and organ recovery at the donation sites. Neurocritical care teams and donation physicians at the donation site and independent of transplant teams will implement neuromonitoring using the following modalities: 1. Transcranial colour-coded Doppler (TCCD) as a measure of brain blood flow, 2. Electroencephalography (EEG), as a measure of cortical brain electrophysiologic activity, and 3. Somatosensory evoked potentials (SSEP) or brainstem auditory evoked potentials (BAEP), as a measure of brainstem electrophysiologic activity. The neuromonitoring team will interpret observed signals in real-time during the A-NRP process. This study will confirm whether current A-NRP surgical safeguards ensure maintenance of permanent cessation of brain blood flow and/or activity during A-NRP and will guide the adoption of A-NRP in Ontario.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• = 18 years of age
• Potential DCC donors whose families/surrogate decision makers have consented to DCC organ donation according to current criteria of the participating transplant programs. These may include patients donating a liver, kidneys, pancreas, and/or lungs; please see Appendix A for organ specific donor inclusion criteria.

Exclusion Criteria:

• < 18 years of age
• DCC donors who proceed to donation following medical assistance in dying or those who are able to provide first-person consent at the time of donation
• Injuries that anatomically preclude the use of neurological monitoring

Related Conditions & MeSH terms

• Organ Transplant

Intervention

Other:
• Neuromonitoring
Multimodal neuromonitoring will include: Transcranial colour-coded Doppler (TCCD), Electroencephalography (EEG), and Somatosensory evoked potentials (SSEP) or brainstem auditory evoked potentials (BAEP)

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Western University, Canada	University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Donor resumption of brain blood flow and/or activity	Proportion of enrolled patients who have resumption of brain blood flow and/or activity during A-NRP on any neuromonitor and that is confirmed by neurocritical care physician and that results in termination of A-NRP	Through study completion, an average of 1 year
Secondary	Donor accrual rate	Number of eligible donors who are enrolled in the study and complete study procedures	Through study completion, an average of 1 year
Secondary	Consent rate	Number of donors who consent to study procedures divided by the number of donors approached for study consent (target = 80%)	Through study completion, an average of 1 year
Secondary	Neuromonitoring modalities	Number of neuromonitoring modalities used per patient and reasons for excluding specific modalities	Through study completion, an average of 1 year
Secondary	Duration and proportion of neuromonitoring signal	Duration of continuous neuromonitoring and proportion of total recording time with adequate signal per patient (velocity waveforms for TCCD, uv/mm for EEG, brainstem auditory evoked potentials (BAEP) signal, and somatosensory evoked potentials (SSEP) signal)	Through study completion, an average of 1 year
Secondary	Neuromonitoring failure	Proportion of enrolled patients who had failure of neuromonitoring equipment during recording	Through study completion, an average of 1 year