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NCT Number: NCT05581745

A2 to O Lung Transplants

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.

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Key information

Conditions

Lung Transplant ABO Incompatibility

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto General Hospital, University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location status: Recruiting

Location contact

Meghan Aversa, MD MSc

SUB_INVESTIGATOR

Shaf Keshavjee, MD MSc

PRINCIPAL_INVESTIGATOR

Sharaniyaa Balachandran

CONTACT

[email protected]

416-340-4800 ext. 6549

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sharaniyaa Balachandran

CONTACT

[email protected]

416-340-4800 ext. 6549

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Blood Group A2 Donor to Blood Group O Recipient Lung Transplantation

Important dates

Study start
2022
Primary completion
2026
Study completion
2033
First posted
Oct 14, 2022
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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