A2 to O Lung Transplants

February 3, 2025 updated by: University Health Network, Toronto

Blood Group A2 Donor to Blood Group O Recipient Lung Transplantation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • Toronto General Hospital, University Health Network
        • Contact:
        • Principal Investigator:
          • Shaf Keshavjee, MD MSc
        • Sub-Investigator:
          • Meghan Aversa, MD MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A2 donor transplant to O recipient
Procedure: 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Shaf Keshavjee, MD MSc FRCSC FACS, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2033

Study Registration Dates

First Submitted

October 11, 2022

First Submitted That Met QC Criteria

October 11, 2022

First Posted (Actual)

October 14, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 21-5005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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