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)

Lung Transplantation Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02855372
• Other study ID #: 2015-39
• Status: Not yet recruiting
• Phase: N/A
• First received: August 1, 2016
• Last updated: August 3, 2016
• Start date: October 2016
• Est. completion date: April 2018

Study information

• Verified date: August 2016
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Urielle DESALBRES
• Phone: 04 91 38 20 61
• Email: urielle.desalbres[@]ap-hm.fr
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: April 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Lung Transplantation

Intervention

Procedure:
• Lung transplantation

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Marseille, Hôpital Nord	Marseille Cedex 01

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes