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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 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: August 6, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
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™
Device: STEEN Solution™
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 10
Study Start Date: September 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
No Intervention: Lung transplant from conventional brain-dead organ donor
No experimental procedures will be carried out.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615484

Contacts
Contact: Thomas M Egan, MD, MSc, FACS 919-966-3381 thomas_egan@med.unc.edu

Locations
United States, North Carolina
UNC-Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Thomas M Egan, MD, MSc., FACS    919-966-3381    thomas_egan@med.unc.edu   
Principal Investigator: Thomas M. Egan, MD, MSc.         
Sub-Investigator: Peadar Noone, MD         
Sub-Investigator: Benjamin Haithcock, MD         
Sub-Investigator: Katherine Birchard, MD         
Sub-Investigator: Jason Long, MD, MPH         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Earl Schwark    919-681-5775    earl.schwark@duke.edu   
Sub-Investigator: R. Duane Davis, MD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Duke University
Vitrolife
XVIVO Perfusion
Investigators
Principal Investigator: Thomas M. Egan, MD, MSc. UNC-Chapel Hill
  More Information

Additional Information:
Publications:

Responsible Party: Tom Egan, MD,MsC, Professor of Surgery, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01615484     History of Changes
Other Study ID Numbers: UNC-002 Vitrolife, 1UM1HL113115-01A1
Study First Received: June 6, 2012
Last Updated: August 6, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:
Lung Transplant
Emphysema
Chronic Obstructive Pulmonary Disease (COPD)
Cystic Fibrosis
Pulmonary Fibrosis
Bronchiectasis
Sarcoidosis
Pulmonary Hypertension
Alpha-1 Antitrypsin Deficiency

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pulmonary Fibrosis
Hypertension, Pulmonary
Lung Diseases
Cystic Fibrosis
Fibrosis
Hypertension
Emphysema
Sarcoidosis
Bronchiectasis
Alpha 1-Antitrypsin Deficiency
Pancreatic Diseases
Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Bronchial Diseases
Liver Diseases
Subcutaneous Emphysema
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014