Impact of the Age Difference Between the Donor and Recipient on the Morbidity and Mortality After Lung Transplantation. Study on a National Multicenter Cohort (COLT)

• Conditions: Lung Transplantation
• Interventions: Procedure: Lung transplantation

• Registration Number: NCT02855372
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

It is commonly accepted that the characteristics of the organ donor impact on the future post transplant. In lung transplantation (LP), the defining characteristics of the "ideal" donor includes an age less than 55 years. However, before the pulmonary graft shortage with a corresponding mortality still too high waiting list, the lung graft acceptance criteria were reassessed permitting criteria "extension" ( "marginal" graft). And were grafted, depending on the urgency and accessibility problems in the registry of potential candidate, organs from donors aged 55 and older with quite comparable to those obtained from younger donors . Nevertheless, it is common practice that the grafts from older donors are more readily allocated to older candidates and the most severe, as many confounding factors to assess the real impact of donor age on post-transplant evolution on small cohorts.

The main goal of this study is to compare the survival of lung transplant patients depending on the age difference between donor and recipient.

The study will be conducted from a broad national cohort of lung transplant patients registered in COLT ( Lung Transplantation COhort). Established in September 2009, promoted by the University Hospital of Nantes, COLT involves 11 lung transplant centers authorized on French territory. It provides a standardized common longitudinal monitoring of the recipient from his transplant. Currently more than 1,000 patients included in this study are transplanted.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-08
• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-08-03
• Last Update Submitted: 2016-08-03
• Study First Posted: 2016-08-04
• Last Update Posted: 2016-08-04
• Study Start: 2016-10
• Primary Completion: 2017-10
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• Male or female adult patients, included in COLT cohort, thus having given a signed written consent
• Who received a lung transplant

Exclusion Criteria

• Lung transplanted patients in a context of national priority
• Lung transplanted patients who died within 3 months after the surgery
• Patients for whom it is a second lung transplantation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lung transplanted patients	Lung transplantation	-

Primary Outcome Measures

Name	Time	Method
Age difference in years between donor and recipient	1 day	The age difference will then be able to define two groups of patients: * 1 group with an age difference \< 10 years; * 1 group with an age difference \> 10 years

Trial Locations

Locations (1)

Assistance Publique Hôpitaux de Marseille, Hôpital Nord; 🇫🇷 Marseille Cedex 01, France