EVLP to Evaluate the Eligibility for Transplantation of DCD-Lungs

Phase 1UnknownNCT02061462

Policlinico Hospital10 enrolled

Overview

The procurement of organs from donors after cardiocirculatory death (DCD) is an accepted strategy to increase organ supply.

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Interventions

EVLP-DCD GroupPROCEDURE

Events: application of an open lung protective ventilatory strategy (recruitment manoeuvre, low volume-low frequency ventilation-high PEEP) to the DCD donors; procurement of lungs and cold storage on ice; reconditioning/evaluation by EVLP to assess suitability for transplantation; cold storage on ice; transplantation. Endpoints of suitability: oxygenation, respiratory mechanics, pulmonary vascular resistance, chest X-ray, fibrobronchoscopy

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

Lung donors: * subjects with brain death according to neurological or cardiocirculatory criteria * age below 65 yrs * absence of massive lung contusion, aspiration, pneumonia, sepsis * absence of infection, malignancy Recipients: * subjects to undergo single or bilateral lung transplantation * informed consent to participate in the study

Locations (1)

Fondazione IRCCS a' Granda - Ospedale Maggiore Policlinico

Milan, Milan, Italy

RECRUITING

Outcomes

Primary Outcomes

30 Day Mortality and Graft Survival

30 day mortality and graft survival is used as a standard research measure to evaluate post transplant outcome

Time frame: 30 days

Secondary Outcomes

Duration of mechanical ventilation after transplantation

Time frame: 30 days

ICU length of stay after transplantation

Time frame: 30 days

Primary Graft Dysfunction 72 hours After Transplantation

Primary Graft Dysfunction 72 hours after transplantation definition: grade 3 according to the International Society of Heart and Lung Transplantation classification

Time frame: 72 hours

Data from ClinicalTrials.gov

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