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

This study is currently recruiting participants.
Verified October 2013 by University of North Carolina, Chapel Hill
Sponsor:
Collaborators:
Duke University
Vitrolife
XVIVO Perfusion
Information provided by (Responsible Party):
Tom Egan, MD,MsC, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01615484
First received: June 6, 2012
Last updated: October 7, 2013
Last verified: October 2013

June 6, 2012
October 7, 2013
September 2013
July 2016   (final data collection date for primary outcome measure)
  • 30 Day Mortality and Graft Survival [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
    The primary objective evaluated for this study is recipient mortality and graft survival at 30 days post transplant. 30 day mortality and graft survival is used as a standard research assessment to evaluate post transplant outcomes.
  • Primary Lung Graft Dysfunction (PGD) [ Time Frame: 24 and 72 hours ] [ Designated as safety issue: Yes ]
    Primary Lung Graft Dysfunction (PGD) is an indicator for significant morbidity and mortality after lung transplantation.
Same as current
Complete list of historical versions of study NCT01615484 on ClinicalTrials.gov Archive Site
  • ICU Length of Stay [ Time Frame: Time to Discharge. ] [ Designated as safety issue: Yes ]
    The length of ICU stay is another standard research and clinical outcome assessment post transplant and has been selected as a secondary objective.
  • Day 7 Ventilator/ECMO Status [ Time Frame: 7 Days Post Transplant. ] [ Designated as safety issue: Yes ]
    7 days ventilator or extra-corporeal membrane oxygenator (ECMO) free are being evaluated as secondary objectives.
  • Recipient mortality at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Recipient mortality at 12 months post transplant is being evaluated as a secondary objective.
  • Bronchiolitis Obliterans Syndrome (BOS) free graft survival. [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    Bronchiolitis Obliterans Syndrome (BOS) free graft survival at 12 months is being used as a secondary outcome.
  • ICU Length of Stay [ Time Frame: Time to Discharge. ] [ Designated as safety issue: Yes ]
    The length of ICU stay is another standard research and clinical outcome assessment post transplant and has been selected as a secondary objective.
  • Day 7 Ventilator/ECMO Status [ Time Frame: 7 Days Post Transplant. ] [ Designated as safety issue: Yes ]
    7 days ventilator or extra-corporeal membrane oxygenator (ECMO) free are being evaluated as secondary objectives.
  • Recipient mortality at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Recipient mortality at 12 months post transplant is being evaluated as a secondary objective.
  • Bronchiolitis Obliterans Syndrome (BOS) free graft survival. [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    Bronchiolitis Obliterans Syndrome (BOS) free graft survival at 12 months is being used as a sencondary outcome.
Not Provided
Not Provided
 
Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability
Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability

The purpose of this research study is to learn about the safety of transplanting lungs obtained from non-heart-beating donors (NHBDs) that have been ventilated (attached to a breathing machine or ventilator to deliver oxygen) and perfused with a lung perfusion solution (Steen solution™, made by Vitrolife). This ventilation and perfusion will be done outside the body (ex-vivo) in a modified cardiopulmonary bypass circuit (the kind of device used routinely during most heart surgeries). The purpose of performing ex-vivo perfusion and ventilation is to learn how well the lungs work, and whether they are likely safe to transplant.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Emphysema
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Cystic Fibrosis
  • Pulmonary Fibrosis
  • Bronchiectasis
  • Sarcoidosis
  • Pulmonary Hypertension
  • Alpha-1 Antitrypsin Deficiency
  • 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.
  • Experimental: Ex-vivo lung perfusion with STEEN Solution™
    The perfusion of the lungs will be performed using STEEN Solution™. The lungs will be physiologically assessed during ex vivo perfusion with STEEN Solution™ perfusate.
    Interventions:
    • Procedure: Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™
    • Device: STEEN Solution™
  • No Intervention: Lung transplant from conventional brain-dead organ donor
    No experimental procedures will be carried out.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
July 2017
July 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A recipient must meet the following requirement to enroll into the study:
  • Requires a single or bilateral lung transplant and is listed for transplant at UNC or Duke
  • Male or Female, 15 years of age or older.
  • Subject or Subject's Representative provides a legally effective informed consent.
  • Recipient does not have HIV, active Hepatitis or is colonized with Burkholderia cepacia.
  • Potential subjects who have undergone previous lung transplants and meet all other inclusion criteria, are eligible for study participation.

Exclusion Criteria:

•Recipient fails to meet standard of care requirements for lung transplant, or decides not to participate.

Both
15 Years and older
No
Contact: Thomas M Egan, MD, MSc, FACS 919-966-3381 thomas_egan@med.unc.edu
United States
 
NCT01615484
UNC-002 Vitrolife, 1UM1HL113115-01A1
Yes
Tom Egan, MD,MsC, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
  • Duke University
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Vitrolife
  • XVIVO Perfusion
Principal Investigator: Thomas M. Egan, MD, MSc. UNC-Chapel Hill
University of North Carolina, Chapel Hill
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP