NCT02906436

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

5.8 years

First QC Date

September 11, 2016

Last Update Submit

April 19, 2017

Conditions

Lung Transplantation

Keywords

Lung transplantationExVivo reconditionning

Outcome Measures

Primary Outcomes (1)

  • number of "transplantable" grafts and Reduced waiting time before transplantation

    12 months

Secondary Outcomes (4)

  • 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

Study Arms (1)

ExVivo lung reconditioning

EXPERIMENTAL
Device: Xvivo Chamber

Interventions

Xvivo ChamberDEVICE
ExVivo lung reconditioning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients under tutorship or unable to consent or institutionalized

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre chirugical Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

Hopital Foch

Suresnes, 92150, France

Location

Study Officials

  • Alain Chapelier, PhD

    Hopital Foch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2016

First Posted

September 20, 2016

Study Start

February 1, 2011

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

April 20, 2017

Record last verified: 2017-04

Locations

FR(2)