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Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability

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ClinicalTrials.gov Identifier: NCT01241942
Recruitment Status : Terminated (Funding exhausted.)
First Posted : November 16, 2010
Last Update Posted : July 13, 2018
Sponsor:
Collaborators:
Vitrolife
XVIVO Perfusion
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE November 12, 2010
First Posted Date  ICMJE November 16, 2010
Last Update Posted Date July 13, 2018
Study Start Date  ICMJE December 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2010)
30 Day Mortality [ Time Frame: 30 Days ]
The primary objective evaluated for this study is recipient mortality at 30 days post transplant. 30 day mortality is used as a standard research assessment to evaluate post transplant outcomes.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
  • Primary Lung Graft Dysfunction (PGD) [ Time Frame: 24 and 72 hours post transplant. ]
    Primary Lung Graft Dysfunction (PGD) is an indicator for significant morbidity and mortality after lung transplantation. Grade 0: PaO2*/FIO2** > 300 with normal chest radiograph; Grade 1: PaO2/FIO2 > 300 with diffuse infiltrates on the chest radiograph; Grade 2: PaO2/FIO2 between 200 and 300; Grade 3: PaO2/FIO2 < 200. * partial pressure of oxygen in the arterial blood (PaO2) ** fraction of inspired oxygen inspired oxygen fraction (FIO2)
  • ICU Length of Stay [ Time Frame: Time to Discharge. ]
    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. ]
    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 ]
    Recipient mortality at 12 months post transplant is being evaluated as a secondary objective.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2010)
  • Primary Lung Graft Dysfunction (PGD) [ Time Frame: 24 and 72 hours post transplant. ]
    Primary Lung Graft Dysfunction (PGD) is an indicator for significant morbidity and mortality after lung transplantation. PGD at 24 and 72 hours post LTX are secondary objectives.
  • ICU Length of Stay [ Time Frame: Time to Discharge. ]
    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. ]
    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 ]
    Recipient mortality at 12 months post transplant is being evaluated as a secondary objective.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability
Official Title  ICMJE Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability
Brief Summary The purpose of this research study is to perfect the technique of EVLP and learn about the safety of transplanting lungs 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 lung perfusion and ventilation (EVLP) is to learn how well the lungs work, and whether they are likely safe to transplant.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE
  • Emphysema
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Cystic Fibrosis
  • Pulmonary Fibrosis
  • Bronchiectasis
  • Sarcoidosis
  • Pulmonary Hypertension
  • Alpha-1 Antitrypsin Deficiency
Intervention  ICMJE
  • 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. After EVLP, lungs will be cooled in the circuit to room temperature, then flushed with cold Perfadex™ and taken to UNC Hospitals (UNCH) where they will have an ex-vivo CT scan. Lungs determined suitable will be offered to consented patients at UNCH 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 with Steen Solution™ will be transplanted into recipients as per current clinical practice.
  • Other: Conventional Lung Transplant
    No experimental procedures will be carried out. Lungs from conventional brain-dead organ donors will be used for transplant.
Study Arms  ICMJE
  • Experimental: EVLP with STEEN Solution™
    The perfusion of the lungs will be performed using STEEN Solution™ and then physiologically assessed. Lungs deemed suitable will be transplanted after Ex-vivo Perfusion w/ STEEN Solution™.
    Intervention: Device: Steen Solution™
  • Active Comparator: Conventional Lung transplant
    No experimental procedures will be carried out. Lungs from conventional brain-dead organ donors will be used for transplant.
    Intervention: Other: Conventional Lung Transplant
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 11, 2018)
11
Original Estimated Enrollment  ICMJE
 (submitted: November 15, 2010)
20
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Lung Recipient 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 lung transplant at UNC.
  • Male or Female, 18 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.

Lung Recipient Exclusion Criteria:

  • Recipient fails to meet standard of care requirements for lung transplant, or decides not to participate.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01241942
Other Study ID Numbers  ICMJE UNC-001 Vitrolife
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE
  • Vitrolife
  • XVIVO Perfusion
Investigators  ICMJE
Principal Investigator: Thomas M. Egan, MD, MSc. UNC-Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date July 2018

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