Ex-Vivo Lung Reconditioning

Not Applicable

Completed

• Conditions: Lung Transplantation
• Interventions: Device: Xvivo Chamber

• Registration Number: NCT02906436
• Lead Sponsor: Hopital Foch

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2016-09-11
• Study First Submitted QC: 2016-09-14
• Study First Posted: 2016-09-20
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

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Exclusion Criteria

-Patients under tutorship or unable to consent or institutionalized

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ExVivo lung reconditioning	Xvivo Chamber	-

Primary Outcome Measures

Name	Time	Method
number of "transplantable" grafts and Reduced waiting time before transplantation	12 months

Secondary Outcome Measures

Name	Time	Method
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
Number of deaths of patients on waiting list	5 years
survival time after lung transplantation with ExVivo lung reconditioning	1 year after end of study
Quality of life scale score after lung transplantation with ExVivo lung reconditioning	1 year after end of study

Trial Locations

Locations (2)

Centre chirugical Marie Lannelongue; 🇫🇷 Le Plessis Robinson, France

Hopital Foch; 🇫🇷 Suresnes, France