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

Policlinico Hospital

Status and phase: Unknown; Phase 1

Conditions: Graft Failure; Disorders Related to Lung Transplantation

Treatments: Procedure: EVLP-DCD Group

Study type: Interventional

Funder types: Other

Identifiers

NCT02061462

EVLP_2013

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Standard Group

No Intervention group

Description:

Recipients of lungs procured from brain dead donors.

EVLP-DCD Group

Active Comparator group

Description:

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

Treatment:

Procedure: EVLP-DCD Group