A2 to O Lung Transplants

NCT ID: NCT05581745

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-14

Study Completion Date

2033-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Transplant ABO Incompatibility

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A2 donor transplant to O recipient

Group Type EXPERIMENTAL

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

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shaf Keshavjee, MD MSc FRCSC FACS

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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Toronto General Hospital, University Health Network

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Sharaniyaa Balachandran

Role: CONTACT

416-340-4800 ext. 6549

Facility Contacts

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Sharaniyaa Balachandran

Role: primary

416-340-4800 ext. 6549

Other Identifiers

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21-5005

Identifier Type: -

Identifier Source: org_study_id

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