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Ex-Vivo Lung Reconditioning (ExVivo)

H

Hopital Foch

Status

Completed

Conditions

Lung Transplantation

Treatments

Device: Xvivo Chamber

Study type

Interventional

Funder types

Other

Identifiers

NCT02906436
2010/36
2010-A00879-30 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

45 participants in 1 patient group

ExVivo lung reconditioning
Experimental group
Treatment:
Device: Xvivo Chamber

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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