EVLP to Evaluate the Eligibility for Transplantation of DCD-Lungs (EVLP-DCD)

November 25, 2014 updated by: Franco Valenza, MD, Policlinico Hospital

Extracorporeal Lung Perfusion and Ventilation to Evaluate the Eligibility for Transplantation of Lungs Retrieved From Donors After Cardio-circulatory Death (DCD)

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Anticipated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20122
        • Recruiting
        • Fondazione IRCCS a' Granda - Ospedale Maggiore Policlinico
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Standard Group
Recipients of lungs procured from brain dead donors.
ACTIVE_COMPARATOR: EVLP-DCD Group
Recipients of lungs procured from DCD donors, reconditioned/evaluated by EVLP
Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30 Day Mortality and Graft Survival
Time Frame: 30 days
30 day mortality and graft survival is used as a standard research measure to evaluate post transplant outcome
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of mechanical ventilation after transplantation
Time Frame: 30 days
30 days
ICU length of stay after transplantation
Time Frame: 30 days
30 days
Primary Graft Dysfunction 72 hours After Transplantation
Time Frame: 72 hours
Primary Graft Dysfunction 72 hours after transplantation definition: grade 3 according to the International Society of Heart and Lung Transplantation classification
72 hours

Other Outcome Measures

Outcome Measure
Time Frame
Bronchiolitis Obliterans Syndrome (BOS)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Policlinico Hospital

Collaborators

San Gerardo Hospital

Investigators

  • Principal Investigator: Franco Valenza, MD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ANTICIPATED)

October 1, 2016

Study Completion (ANTICIPATED)

April 1, 2017

Study Registration Dates

First Submitted

February 11, 2014

First Submitted That Met QC Criteria

February 11, 2014

First Posted (ESTIMATE)

February 12, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

November 26, 2014

Last Update Submitted That Met QC Criteria

November 25, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • EVLP_2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Graft Failure

Clinical Trials on EVLP-DCD Group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe