Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability

NACompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

March 31, 2016

Study Completion Date

January 31, 2017

Conditions
EmphysemaChronic Obstructive Pulmonary Disease (COPD)Cystic FibrosisPulmonary FibrosisBronchiectasisSarcoidosisPulmonary HypertensionAlpha-1 Antitrypsin Deficiency
Interventions
PROCEDURE

Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™

After EVLP, lungs will be cooled in the circuit to room temperature, then flushed with cold Perfadex™, and taken to UNCH where they will have an ex-vivo CT scan. Lungs determined suitable will be offered to consented patients at UNC Hospitals and Duke University Medical Center based on Lung Allocation Score. Lungs not considered for transplantation may be subjected to different experiments but are not to be a part of this research study. In summary, lungs with good and stable function during EVLP will be transplanted into recipients as per current clinical practice.

DEVICE

STEEN Solution™

This solution is a buffered dextran and albumin-containing extracellular perfusate with an optimal colloid osmotic pressure developed specifically for extra-corporeal perfusion of lungs.

Trial Locations (2)

27599

UNC-Chapel Hill, Chapel Hill

27710

Duke University Medical Center, Durham

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Duke University

OTHER

collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

Vitrolife

INDUSTRY

collaborator

XVIVO Perfusion

INDUSTRY

lead

University of North Carolina, Chapel Hill

OTHER

NCT01615484 - Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability | Biotech Hunter | Biotech Hunter