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

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ClinicalTrials.gov Identifier: NCT05195853
Recruitment Status : Recruiting
First Posted : January 19, 2022
Last Update Posted : December 30, 2022
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Brief Summary:

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.

Condition or disease
Lung Transplant

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Optimization of Donor-Recipient Matching in Lung Transplantation
Actual Study Start Date : January 15, 2022
Estimated Primary Completion Date : November 15, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

  2. Number of hospitalization at Year 1 [ Time Frame: Year 1 ]
    This outcome corresponds to the number of hospitalization during the first year.

  3. 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.

  4. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05195853

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Contact: Anne Buronfosse, MD 144123873 ext +33 aburonfosse@ghpsj.fr
Contact: Helene BEAUSSIER, PharmD, PhD 0144127883 ext +33 crc@ghpsj.fr

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Groupe Hospitalier Paris Saint-Joseph Recruiting
Paris, France, 75014
Contact: Anne Buronfosse, MD         
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
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Principal Investigator: Anne Buronfosse, MD Groupe Hospitalier Paris Saint Joseph

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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT05195853    
Other Study ID Numbers: ADRTP
First Posted: January 19, 2022    Key Record Dates
Last Update Posted: December 30, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No