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RecruitingNCT05581745Updated Sep 29, 2026

A2 to O Lung Transplants

An interventional study of Blood group A2 donor to blood group O recipient lung transplant surgery in Lung Transplant and ABO Incompatibility, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Lung Transplant
  • ABO Incompatibility
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • first lung transplant
  • blood group O recipient
  • low pre-operative anti-A antibody titers
  • consent to study participation

Exclusion criteria

Exclusion Criteria:

  • re-transplant
  • multiorgan transplant
  • positive virtual crossmatch at time of transplant
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    A2 donor transplant to O recipient

    Procedure: Blood group A2 donor to blood group O recipient lung transplant surgery

Interventions

  • ProcedureBlood group A2 donor to blood group O recipient lung transplant surgery

    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

05

What researchers measure

Primary outcomes

  1. Post-transplant anti-A antibody titers

    Time frame: post-op day 5 or day 12

  2. Primary graft dysfunction grade

    Time frame: post-op day 0, 1, 2, 3

  3. Incidence of hyperacute antibody-mediated rejection

    Time frame: post-op day 1, 2

  4. C4d positivity on transbronchial biopsy samples

    Time frame: 1 year

  5. Incidence and severity of acute cellular rejection

    Time frame: 1 year

  6. Bleeding

    Time frame: post-op day 1-7

  7. Infection

    Time frame: 10 years

  8. Graft function

    Time frame: 10 years

  9. Incidence of malignancy

    Time frame: 10 years

  10. Chronic lung allograft dysfunction

    Time frame: 10 years

  11. Time to death or re-transplantation

    Time frame: 10 years

06

Study locations

1 of 1 sites recruiting
  • Toronto General Hospital, University Health Network
    Toronto, Ontario M5G 2C4, Canada
    • Sharaniyaa Balachandran · Contact · sharaniyaa.balachandran@uhn.ca · 416-340-4800
    • Shaf Keshavjee, MD MSc · Principal investigator
    • Meghan Aversa, MD MSc · Sub investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT05581745
Lead sponsor
University Health Network, Toronto
Responsible party
Sponsor
First posted
Oct 14, 2022
Start date
Jul 14, 2022
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2033 (estimated)
Last update
Sep 29, 2026

Study contacts

Sharaniyaa Balachandran
Contact
sharaniyaa.balachandran@uhn.ca
416-340-4800 ext. 6549
Shaf Keshavjee, MD MSc FRCSC FACS
principal investigator · University Health Network, Toronto

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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