NCT05884736 Confirming Permanent Lack of Blood Flow to the Brain During A-NRP DCC Organ Transplant
| NCT ID | NCT05884736 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Western University, Canada |
| Condition | Organ Transplant |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-04-02 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2024-04-02 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Anton Skaro, MD PhD
PRINCIPAL INVESTIGATOR
London Health Sciences Centre/Lawson Health Research Institute
Frequently Asked Questions
Who can join the NCT05884736 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Organ Transplant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05884736 currently recruiting?
Yes, NCT05884736 is actively recruiting participants. Contact the research team at Crystal.Engelage@lhsc.on.ca for enrollment information.
Where is the NCT05884736 trial being conducted?
This trial is being conducted at London, Canada, Toronto, Canada.
Who is sponsoring the NCT05884736 clinical trial?
NCT05884736 is sponsored by Western University, Canada. The principal investigator is Anton Skaro, MD PhD at London Health Sciences Centre/Lawson Health Research Institute. The trial plans to enroll 30 participants.