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A2 to O Lung Transplants

Not Applicable
Recruiting
Conditions
Lung Transplant
ABO Incompatibility
Interventions
Procedure: Blood group A2 donor to blood group O recipient lung transplant surgery
Registration Number
NCT05581745
Lead Sponsor
University Health Network, Toronto
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
10
Inclusion Criteria
  • first lung transplant
  • blood group O recipient
  • low pre-operative anti-A antibody titers
  • consent to study participation
Read More
Exclusion Criteria
  • re-transplant
  • multiorgan transplant
  • positive virtual crossmatch at time of transplant
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
A2 donor transplant to O recipientBlood group A2 donor to blood group O recipient lung transplant surgery-
Primary Outcome Measures
NameTimeMethod
Bleedingpost-op day 1-7
Incidence of malignancy10 years
C4d positivity on transbronchial biopsy samples1 year
Graft function10 years
Post-transplant anti-A antibody titerspost-op day 5 or day 12
Primary graft dysfunction gradepost-op day 0, 1, 2, 3
Incidence of hyperacute antibody-mediated rejectionpost-op day 1, 2
Incidence and severity of acute cellular rejection1 year
Chronic lung allograft dysfunction10 years
Time to death or re-transplantation10 years
Infection10 years
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Toronto General Hospital, University Health Network

🇨🇦

Toronto, Ontario, Canada

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