A2 to O Lung Transplants
Blood Group A2 Donor to Blood Group O Recipient Lung Transplantation
1 other identifier
interventional
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 14, 2022
CompletedFirst Submitted
Initial submission to the registry
October 11, 2022
CompletedFirst Posted
Study publicly available on registry
October 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2033
February 6, 2025
February 1, 2025
4.5 years
October 11, 2022
February 3, 2025
Conditions
Outcome Measures
Primary Outcomes (11)
Post-transplant anti-A antibody titers
post-op day 5 or day 12
Primary graft dysfunction grade
post-op day 0, 1, 2, 3
Incidence of hyperacute antibody-mediated rejection
post-op day 1, 2
C4d positivity on transbronchial biopsy samples
1 year
Incidence and severity of acute cellular rejection
1 year
Bleeding
post-op day 1-7
Infection
10 years
Graft function
10 years
Incidence of malignancy
10 years
Chronic lung allograft dysfunction
10 years
Time to death or re-transplantation
10 years
Study Arms (1)
A2 donor transplant to O recipient
EXPERIMENTALInterventions
Suitable 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
Eligibility Criteria
You may qualify if:
- first lung transplant
- blood group O recipient
- low pre-operative anti-A antibody titers
- consent to study participation
You may not qualify if:
- re-transplant
- multiorgan transplant
- positive virtual crossmatch at time of transplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G 2C4, Canada
Study Officials
- PRINCIPAL INVESTIGATOR
Shaf Keshavjee, MD MSc FRCSC FACS
University Health Network, Toronto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2022
First Posted
October 14, 2022
Study Start
July 14, 2022
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2033
Last Updated
February 6, 2025
Record last verified: 2025-02