EVLP to Evaluate the Eligibility for Transplantation of DCD-Lungs

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02061462

Acronym

EVLP-DCD

Enrollment

Registered

2014-02-12

Start date

2014-10-31

Completion date

2017-04-30

Last updated

2014-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorders Related to Lung Transplantation, Graft Failure

Brief summary

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

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.

Interventions

PROCEDUREEVLP-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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Other

Measure	Time frame
Bronchiolitis Obliterans Syndrome (BOS)	12 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026