Confirming Permanent Lack of Blood Flow to the Brain During A-NRP DCC Organ Transplant (NCT05884736) | Clinical Trial Compass
RecruitingNot Applicable
Confirming Permanent Lack of Blood Flow to the Brain During A-NRP DCC Organ Transplant
Canada30 participantsStarted 2024-04-02
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying whether blood flow to the brain truly stops permanently during a procedure called A-NRP DCC organ donation — can you explain what A-NRP DCC is and why confirming the absence of brain blood flow matters for this type of donation?
2Since the primary outcome is measuring whether brain blood flow or activity ever resumes in donors during this procedure, what does that mean ethically and medically, and how might findings from this study affect how organ donation is practiced in the future?
3This trial is listed as Phase NA, which suggests it may be observational or confirmatory rather than testing a new treatment — can you help me understand what role participants or their families might actually play in this study?
4Given that this research involves donors and the organ donation process itself, who exactly would be enrolled in this trial, and is this something that would involve a decision made by a patient before death or by their family afterward?
5Are there any current concerns or ongoing debates in the medical community about whether A-NRP DCC donation fully meets brain death criteria, and how might the results of this trial influence those discussions for our family's decision-making?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Donor resumption of brain blood flow and/or activity
Timeframe: Through study completion, an average of 1 year