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NCT02906436 Clinical Trial

Ex-Vivo Lung Reconditioning

Lung Transplantation Clinical Trial

— ExVivo  

Official title:
Pilot Study of Lung Transplantation After Ex-Vivo Lung Reconditioning

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02906436
Other study ID # 2010/36
Secondary ID 2010-A00879-30
Status Completed
Phase N/A
First received September 11, 2016
Last updated April 19, 2017
Start date February 2011
Est. completion date November 2016

Study information
Verified date April 2017
Source Hopital Foch
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Only about 15% of the potential candidates for lung donation are considered suitable for transplantation. Thus, a strategy that could improve the quality and precision of assessment of nonacceptable donor lungs could have a major impact on reducing waiting time and mortality while on the list.

A new method for ex vivo lung perfusion (EVLP) has been developed recently by Steen and colleagues to assess the quality of lungs from a non-heart-beating donor. The method can also be used to recondition "marginal" and nonacceptable donor lungs.

After harvesting, the lungs were perfused ex vivo with Steen Solution, an extracellular matrix with high colloid osmotic pressure. A membrane oxygenator connected to the circuit received gas from a mixture of nitrogen and carbon dioxide, maintaining a normal mixed venous blood gas level in the perfusate. The lungs were gradually rewarmed, reperfused, and ventilated for evaluation through analyses of oxygenation capacity, pulmonary vascular resistance (PVR), lung compliance (LC), and biopsy.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients on the waiting list for lung transplantation and for which the Biomedicine -Agency has awarded a lung transplantation after Ex-Vivo lung reconditioning

- Patients affiliated to a social security system;

- Patients who consented to participate in writing

Exclusion Criteria:

-Patients under tutorship or unable to consent or institutionalized

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Xvivo Chamber

Locations
Country Name City State
France Centre chirugical Marie Lannelongue Le Plessis Robinson
France Hopital Foch Suresnes

Sponsors (1)
Lead Sponsor Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of "transplantable" grafts and Reduced waiting time before transplantation 12 months
Secondary Difference of data obtained 2 hours after Ex-Vivo lung reconditioning with those obtained 4 hours after Ex-Vivo lung reconditioning 4 hours after Ex-Vivo lung reconditioning
Secondary Number of deaths of patients on waiting list 5 years
Secondary survival time after lung transplantation with ExVivo lung reconditioning 1 year after end of study
Secondary Quality of life scale score after lung transplantation with ExVivo lung reconditioning 1 year after end of study
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