Optimization of Donor-Recipient Matching in Lung Transplantation (ADRTP)

December 29, 2022 updated by: Groupe Hospitalier Paris Saint Joseph

Lung transplantation is the curative treatment for end-stage respiratory failure involving highly selected patients. In 2018, the International Transplant Registry counts 69200 lung transplants among 260 transplant centers. Between 2010 and June 2017, the 3-month survival rate of patients after lung transplantation is 90%. The causes of early death are primary graft failure, renal failure, infections, acute rejection (cellular or humoral), surgical complications. The median survival is 6.7 years and the median conditioned survival at 1 year is 8.9 years. Bronchiolitis obliterans is the leading cause of death after 1 year; it affects 10% more patients each year and peaks at 5 years at more than 50% of transplanted patients. These results encourage transplant professionals to continue their efforts to improve the prognosis of transplantation. Among these, the optimization of graft matching, taking into account the characteristics of the donor and the recipient, constitute a relevant avenue of study. Several donor characteristics seem to play a role in the prognosis of the transplant. Survival at 12 months is significantly worse when the donor's age is greater than 50 years. There does not appear to be a significant difference in donor cause of death. Recipients of a graft exposed to smoking ≥ 20 pack-years have a 3% and 1.5% decreased survival at 1 and 5 years postoperatively.

Similarly, the 5-year survival of patients with conditional 1-year survival is poorer in case of other toxic exposures such as alcohol, cocaine, crack or marijuana. Analysis of international registry data also suggests a negative association between post-transplant survival and donor hypertension and diabetes. However, the biological mechanisms by which these factors affect survival remain unknown. Graft ischemia time is significantly associated with survival with a 5-year survival of 70% and 65% for grafts exposed to ischemia ≥ 4 hours or less. The cumulative effect of donor hypertension and ischemia time are appreciated by the fact that the best postoperative survival is observed in donors without hypertension and graft ischemia time ≥ 4 hours. Graft size is also associated with post-transplant prognosis, in front of a significant decrease in survival for patients with emphysema, chronic obstructive pulmonary disease, alpha-1 antitrypsin deficiency, transplanted with a smaller graft size.

This result is not found in patients transplanted for pulmonary fibrosis. One study has also suggested the negative role of a gender mismatch between donor and recipient on post-transplant survival, but there is currently no clear explanation for this result. The presence of antibodies to the recipient's HLA system [DSA (donor-specific antibodies)] in pre-transplant is a risk factor for hyperacute rejection and chronic graft dysfunction. Thus, the choice of matching between the donor and the recipient appears complex in view of the number of criteria to be taken into account which impact the duration of post-transplant survival in the short and medium term. The objective of the project is to develop a decision support tool, using artificial intelligence algorithms, to assist the thoracic surgeon in identifying the patient, among those registered on the team's waiting list, who could benefit most from a bi-pulmonary graft offered by the Biomedicine Agency.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75014
        • Recruiting
        • Groupe Hospitalier Paris Saint-Joseph
        • Contact:
          • Anne Buronfosse, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

These patients were admitted for a bi-lung transplant performed by the Marie Lannelongue lung transplant team between January 1, 2007 and April 30, 2021.

Description

Inclusion Criteria:

  • Patients who have received a bi-lung transplant performed by the Marie Lannelongue lung transplant team between January 1, 2007 and April 30, 2021 All indications for transplantation will be considered, including retransplantation.
  • French-speaking patient

Exclusion Criteria:

  • Patient is a minor (<18 years old) at the time of transplantation
  • Patient's refusal to participate in the study
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Patient objecting to the use of his/her data for this research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Construction of a tool to predict 90-day survival of patients managed for bi-pulmonary transplantation
Time Frame: Day 90
This outcome corresponds to the number of all-cause deaths within 90 days of transplantation. Deaths occurring during hospitalization or at home are taken into account
Day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction of the risk of a complication during the transplant hospital stay
Time Frame: Day 90
This outcome corresponds to the occurrence of complications during the transplantation hospital stay leading to an increase in the length of hospitalization.
Day 90
Number of hospitalization at Year 1
Time Frame: Year 1
This outcome corresponds to the number of hospitalization during the first year.
Year 1
Number of rejection of the transplant at Year 1
Time Frame: Year 1
This outcome corresponds to the rejection of the transplant during the first year.
Year 1
Respiratory functional benefit in the year following transplantation
Time Frame: Year 1
This outcome corresponds to the functional benefit in terms of respiratory function. This criterion will be assessed on the basis of the results of the EFR performed during the first year post-transplant. The criterion will be the difference between the first post-transplant FEV1 and the best FEV1 obtained during the year under consideration.
Year 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Principal Investigator: Anne BURONFOSSE, MD, Groupe Hospitalier Paris Saint Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2022

Primary Completion (Anticipated)

November 15, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

December 31, 2021

First Submitted That Met QC Criteria

January 18, 2022

First Posted (Actual)

January 19, 2022

Study Record Updates

Last Update Posted (Actual)

December 30, 2022

Last Update Submitted That Met QC Criteria

December 29, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • ADRTP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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