Evaluating brain blood flow during organ transplant procedures
Confirming the Permanent Cessation of Intracranial Circulation During Abdominal Normothermic Regional Perfusion After the Determination of Death by Circulatory Criteria
This study is trying to see if a new way of keeping organs healthy during transplant surgery is safe for brain function in organ donors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Western University, Canada Academic / other |
| Locations | 2 sites (London, Ontario and 1 other locations) |
| Trial ID | NCT05884736 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the surgical technique of Abdominal Normothermic Regional Perfusion (A-NRP) in organ donors determined by circulatory criteria. It will utilize a multimodal neuromonitoring protocol to continuously monitor brain blood flow and activity during the A-NRP procedure. The study will involve multiple centers and will enroll eligible DCC donors, with neurocritical care teams implementing various monitoring techniques such as Transcranial colour-coded Doppler, Electroencephalography, and Somatosensory evoked potentials. The goal is to confirm that there is no resumption of brain blood flow or activity during A-NRP, ensuring donor safety and guiding clinical practice.
Who should consider this trial
Good fit: Ideal candidates for this study are potential organ donors aged 18 years or younger whose families have consented to DCC organ donation.
Not a fit: Patients who may not benefit from this study include those under 18 years of age or those who are able to provide first-person consent at the time of donation.
Why it matters
Potential benefit: If successful, this study could enhance the safety and efficacy of organ donation procedures, potentially increasing the number of viable organs available for transplant.
How similar studies have performed: While this approach is innovative, it builds on existing neuromonitoring techniques; however, the specific application in A-NRP is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
London, Ontario and 1 other locations
- London Health Sciences Centre — London, Ontario, Canada (Recruiting)
- Toronto Western Hospital — Toronto, Ontario, Canada (Not_yet_recruiting)
Study contacts
- Principal investigator: Anton Skaro, MD PhD — London Health Sciences Centre/Lawson Health Research Institute
- Study coordinator: Crystal Engelage, PhD
- Email: Crystal.Engelage@lhsc.on.ca
- Phone: 519-685-8500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.