A2 to O Lung Transplants

Lung Transplant Clinical Trial

Official title:

Blood Group A2 Donor to Blood Group O Recipient Lung Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05581745
• Other study ID #: 21-5005
• Status: Recruiting
• Phase: N/A
• Start date: July 14, 2022
• Est. completion date: December 31, 2032

Study information

• Verified date: January 2024
• Source: University Health Network, Toronto
• Contact: Sharaniyaa Balachandran
• Phone: 416-340-4800
• Email: sharaniyaa.balachandran[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2032
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ABO Incompatibility
• Lung Transplant

Intervention

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

Locations

Country	Name	City	State
Canada	Toronto General Hospital, University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

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