Ex-Vivo Lung Reconditioning (ExVivo)

Pilot Study of Lung Transplantation After Ex-Vivo Lung Reconditioning

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.

Study Overview

• Status: Completed
• Conditions: Lung Transplantation
• Intervention / Treatment: Device: Xvivo Chamber

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Le Plessis Robinson, France, 92350
    • Centre Chirugical Marie Lannelongue
  • Suresnes, France, 92150
    • Hôpital Foch

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ExVivo lung reconditioning	Device: Xvivo Chamber

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of "transplantable" grafts and Reduced waiting time before transplantation	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hopital Foch
• Investigators: Principal Investigator: Alain Chapelier, PhD, Hôpital Foch

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: September 11, 2016
• First Submitted That Met QC Criteria: September 14, 2016
• First Posted (Estimate): September 20, 2016

Study Record Updates

• Last Update Posted (Actual): April 20, 2017
• Last Update Submitted That Met QC Criteria: April 19, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Lung transplantation; ExVivo reconditionning
• Other Study ID Numbers: 2010/36; 2010-A00879-30 (Other Identifier: ANSM)