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Recruiting NCT05581745

A2 to O Lung Transplants

No phase Interventional Lung Transplant ABO Incompatibility

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood group A2 donor to blood group O recipient lung transplant surgery.
Who it may be relevant to
Registry conditions: Lung Transplant, ABO Incompatibility. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Blood Group A2 Donor to Blood Group O Recipient Lung Transplantation

Overview

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.

Interventions

  • 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

Primary outcome measures

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Toronto General Hospital, University Health Network — Toronto

Identifiers

NCT: NCT05581745 · 21-5005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗