EVLP to Evaluate the Eligibility for Transplantation of DCD-Lungs

NCT02061462 | Unknown Phase 1 DMC

• 1 other identifier: EVLP_2013
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Disorders Related to Lung Transplantation; Graft Failure

Outcome Measures

Primary Outcomes (1)

• 30 Day Mortality and Graft Survival

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

  30 days

Secondary Outcomes (3)

• Duration of mechanical ventilation after transplantation

  30 days

• ICU length of stay after transplantation

  30 days

• Primary Graft Dysfunction 72 hours After Transplantation

  72 hours

Other Outcomes (1)

• Bronchiolitis Obliterans Syndrome (BOS)

  12 months

Study Arms (2)

Standard Group

NO INTERVENTION

Recipients of lungs procured from brain dead donors.

EVLP-DCD Group

ACTIVE COMPARATOR

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

Procedure: EVLP-DCD Group

Interventions

EVLP-DCD Group 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

EVLP-DCD Group

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Policlinico Hospital: lead
• San Gerardo Hospital: collaborator

Study Sites (1)

Fondazione IRCCS a' Granda - Ospedale Maggiore Policlinico

Milan, Milan, 20122, Italy

RECRUITING

Study Officials

• Franco Valenza, MD

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Anaesthesia and Intensive Care, Department of Pathophysilogy and Transplantation, Università degli Studi di Milano

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: February 12, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: April 1, 2017
• Last Updated: November 26, 2014

Record last verified: 2014-11

Locations

IT (1)