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EVLP to Evaluate the Eligibility for Transplantation of DCD-Lungs

NCT ID: NCT02061462

Last Updated: 2014-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Disorders Related to Lung Transplantation Graft Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Standard Group

Recipients of lungs procured from brain dead donors.

Group Type NO_INTERVENTION

No interventions assigned to this group

EVLP-DCD Group

Recipients of lungs procured from DCD donors, reconditioned/evaluated by EVLP

Group Type ACTIVE_COMPARATOR

EVLP-DCD Group

Intervention Type PROCEDURE

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

Interventions

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EVLP-DCD Group

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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San Gerardo Hospital

OTHER

Sponsor Role collaborator

Policlinico Hospital

OTHER

Sponsor Role lead

Responsible Party

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Franco Valenza, MD

Assistant Professor Anaesthesia and Intensive Care, Department of Pathophysilogy and Transplantation, Università degli Studi di Milano

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Franco Valenza, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Locations

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Fondazione IRCCS a' Granda - Ospedale Maggiore Policlinico

Milan, Milan, Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Franco Valenza, MD

Role: primary

Other Identifiers

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EVLP_2013

Identifier Type: -

Identifier Source: org_study_id