Ex-Vivo Lung Perfusion to Increase the Number of Organs for Transplantation (EVLP_MI)

Policlinico Hospital

Status and phase: Completed; Phase 1

Conditions: Graft Failure; Primary Graft Dysfunction; Brain Death; Disorder Related to Lung Transplantation

Treatments: Procedure: EVLP Group

Study type: Interventional

Funder types: Other

Identifiers

NCT01967953

EVLP_2011

Details and patient eligibility

About

The recent introduction of ex-vivo lung perfusion (EVLP) as a tool to evaluate and recondition lungs from marginal donors has opened a new era in the field of lung transplantation.

Full description

Aim of the investigation: to compare the clinical outcome after transplantation of subjects receiving marginal lungs procured from brain death donors and reconditioned by EVLP, with that of subjects receiving lungs procured from standard donors.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for donor lung:

1. Recipient to undergo single or bilateral Lung Transplantation
2. Donor arterial partial pressure of oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) below 300 mmHg, or doubtful donor lung function

Exclusion criteria for donor lung:

1. Massive lung contusion
2. Aspiration
3. Pneumonia
4. Sepsis
5. Malignancy

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Standard Group

No Intervention group

Description:

Recipients of lungs procured from brain death donors deemed suitable for transplantation according to standard criteria. Events: lung procurement, cold storage on ice, transplantation.

EVLP Group

Experimental group

Description:

Recipients of marginal lungs procured from brain death donors and reconditioned with ex-vivo lung perfusion (EVLP). Events: lung procurement, cold storage on ice, reconditioning by EVLP, cold storage on ice, transplantation.

Treatment:

Procedure: EVLP Group