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)

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.

Study Overview

• Status: Unknown
• Conditions: Lung Transplantation
• Intervention / Treatment: Procedure: Lung transplantation

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

• Study Contact: Name: Urielle DESALBRES; Phone Number: 04 91 38 20 61; Email: urielle.desalbres@ap-hm.fr

Study Locations

• France
  • Marseille Cedex 01, France, 13915
    • Assistance Publique Hôpitaux de Marseille, Hôpital Nord

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patient who underwent a lung transplantation

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lung transplanted patients	Procedure: Lung transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age difference in years between donor and recipient	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	1 day

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: August 1, 2016
• First Submitted That Met QC Criteria: August 3, 2016
• First Posted (Estimate): August 4, 2016

Study Record Updates

• Last Update Posted (Estimate): August 4, 2016
• Last Update Submitted That Met QC Criteria: August 3, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 2015-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO