A2 to O Lung Transplants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto
About this trial
Blood group A2 to blood group O kidney and liver transplants have been shown to be safe and successful, especially in recipients with low pre-operative anti-A antibody titers and with the use of peri-operative antibody-depleting therapies. Since blood group O lung transplant candidates tend to have longer wait times and a higher waitlist mortality compared to other blood groups, we propose to conduct a prospective study of lung transplantation from blood group A2 donors to eligible blood group O recipients in an effort to increase the available donor pool. The aim of this study is to determine both the feasibility and safety of this specific type of ABO-incompatible lung transplant, and the impact of this practice on reducing transplant wait times among blood group O lung transplant candidates. This would represent the first prospective study of ABO-incompatible lung transplants worldwide.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
first lung transplant
blood group O recipient
low pre-operative anti-A antibody titers
consent to study participation
Disqualifiers
re-transplant
multiorgan transplant
positive virtual crossmatch at time of transplant
Trial design
Design model
Single group
Treatments tested in this trial
Blood group A2 donor to blood group O recipient lung transplant surgery
Procedure/SurgerySuitable blood group A2 donor lung transplant to a consented blood group O recipient who has acceptably low levels of anti-A antibody titres and a negative virtual cross-match at time of transplant
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: A2 donor transplant to O recipientExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Post-transplant anti-A antibody titers
Time frame
post-op day 5 or day 122
Primary graft dysfunction grade
Time frame
post-op day 0, 1, 2, 33
Incidence of hyperacute antibody-mediated rejection
Time frame
post-op day 1, 24
C4d positivity on transbronchial biopsy samples
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov