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Trial record 18 of 20 for:    evlp

Ex-Vivo Lung Reconditioning (ExVivo)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02906436
Recruitment Status : Completed
First Posted : September 20, 2016
Last Update Posted : April 20, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lung Transplantation Device: Xvivo Chamber Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Lung Transplantation After Ex-Vivo Lung Reconditioning
Study Start Date : February 2011
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ExVivo lung reconditioning Device: Xvivo Chamber

Primary Outcome Measures :
  1. number of "transplantable" grafts and Reduced waiting time before transplantation [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Difference of data obtained 2 hours after Ex-Vivo lung reconditioning with those obtained 4 hours after Ex-Vivo lung reconditioning [ Time Frame: 4 hours after Ex-Vivo lung reconditioning ]
  2. Number of deaths of patients on waiting list [ Time Frame: 5 years ]
  3. survival time after lung transplantation with ExVivo lung reconditioning [ Time Frame: 1 year after end of study ]
  4. Quality of life scale score after lung transplantation with ExVivo lung reconditioning [ Time Frame: 1 year after end of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02906436

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Centre chirugical Marie Lannelongue
Le Plessis Robinson, France, 92350
Hopital Foch
Suresnes, France, 92150
Sponsors and Collaborators
Hopital Foch
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Principal Investigator: Alain Chapelier, PhD Hopital Foch

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Responsible Party: Hopital Foch Identifier: NCT02906436     History of Changes
Other Study ID Numbers: 2010/36
2010-A00879-30 ( Other Identifier: ANSM )
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017
Keywords provided by Hopital Foch:
Lung transplantation
ExVivo reconditionning