Recruiting

ABO-Incompatible Lung Transplant

Sponsor:

University Health Network, Toronto

Code:

NCT05581745

Conditions

Lung Transplant

ABO Incompatibility

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

Lung Transplant

ABO Incompatibility

Study ID

NCT05581745

Start date

Jul 14, 2022

Status verified date

Feb, 2025

Completion date

Dec 31, 2033

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: A2 donor transplant to O recipient

Interventions

Blood 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

Primary outcome measure

  • Post-transplant anti-A antibody titers [ Time Frame: post-op day 5 or day 12 ]
  • Primary graft dysfunction grade [ Time Frame: post-op day 0, 1, 2, 3 ]
  • Incidence of hyperacute antibody-mediated rejection [ Time Frame: post-op day 1, 2 ]
  • C4d positivity on transbronchial biopsy samples [ Time Frame: 1 year ]
  • Incidence and severity of acute cellular rejection [ Time Frame: 1 year ]
  • Bleeding [ Time Frame: post-op day 1-7 ]
  • Infection [ Time Frame: 10 years ]
  • Graft function [ Time Frame: 10 years ]
  • Incidence of malignancy [ Time Frame: 10 years ]
  • Chronic lung allograft dysfunction [ Time Frame: 10 years ]
  • Time to death or re-transplantation [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Sharaniyaa Balachandran

416-340-4800sharaniyaa.balachandran@uhn.ca

Locations

Toronto General Hospital, University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Sharaniyaa Balachandran

416-340-4800sharaniyaa.balachandran@uhn.ca

Principal Investigator:

Shaf Keshavjee, MD MSc

More Information

Sponsor

University Health Network, Toronto

Last update posted

Feb 6, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-02-06.