ABO Incompatibility, Lung Transplant
Conditions
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.
Interventions
PROCEDUREBlood 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
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-transplant anti-A antibody titers | post-op day 5 or day 12 |
| Primary graft dysfunction grade | post-op day 0, 1, 2, 3 |
| Incidence of hyperacute antibody-mediated rejection | post-op day 1, 2 |
| C4d positivity on transbronchial biopsy samples | 1 year |
| Incidence and severity of acute cellular rejection | 1 year |
| Bleeding | post-op day 1-7 |
| Infection | 10 years |
| Graft function | 10 years |
| Incidence of malignancy | 10 years |
| Chronic lung allograft dysfunction | 10 years |
| Time to death or re-transplantation | 10 years |
Countries
Canada
Contacts
Primary ContactSharaniyaa Balachandran
Outcome results
None listed