Confirming Permanent Lack of Blood Flow to the Brain During A-NRP DCC Organ Transplant
ConditionOrgan Transplant
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorWestern University, Canada
About this trial
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
Qualifiers
≤ 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.
Disqualifiers
< 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
Trial design
Treatments tested in this trial
- Neuromonitoring
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Western University, Canada
Lead sponsor
University Health Network, Toronto
Collaborator
Source ClinicalTrials.gov