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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02855372
Other study ID # 2015-39
Secondary ID
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


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
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