EVLP to Evaluate the Eligibility for Transplantation of DCD-Lungs

Graft Failure Clinical Trial

— EVLP-DCD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02061462
• Other study ID #: EVLP_2013
• Status: Recruiting
• Phase: Phase 1
• First received: February 11, 2014
• Last updated: November 25, 2014
• Start date: October 2014
• Est. completion date: April 2017

Study information

• Verified date: November 2014
• Source: Policlinico Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Disorders Related to Lung Transplantation
• Graft Failure

Intervention

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

Locations

Country	Name	City	State
Italy	Fondazione IRCCS a' Granda - Ospedale Maggiore Policlinico	Milan

Sponsors (2)

Lead Sponsor	Collaborator
Policlinico Hospital	San Gerardo Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bronchiolitis Obliterans Syndrome (BOS)		12 months	Yes
Primary	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	Yes
Secondary	Duration of mechanical ventilation after transplantation		30 days	Yes
Secondary	ICU length of stay after transplantation		30 days	Yes
Secondary	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	72 hours	Yes