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Trial record 16 of 20 for:    evlp

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

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ClinicalTrials.gov Identifier: NCT01615484
Recruitment Status : Completed
First Posted : June 8, 2012
Results First Posted : April 20, 2018
Last Update Posted : June 8, 2018
Sponsor:
Collaborators:
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Vitrolife
XVIVO Perfusion
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE June 6, 2012
First Posted Date  ICMJE June 8, 2012
Results First Submitted Date  ICMJE March 21, 2018
Results First Posted Date  ICMJE April 20, 2018
Last Update Posted Date June 8, 2018
Study Start Date  ICMJE September 2013
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2018)
  • 30 Day Mortality and Graft Survival [ Time Frame: 30 Days ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2012)
  • 30 Day Mortality and Graft Survival [ Time Frame: 30 Days ]
    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 ]
    Primary Lung Graft Dysfunction (PGD) is an indicator for significant morbidity and mortality after lung transplantation.
Change History Complete list of historical versions of study NCT01615484 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2018)
  • ICU Length of Stay [ Time Frame: Time to Discharge, up to 30 days ]
    The length of ICU stay in days 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. ]
    Participants' status at Day 7 defined as the following: mechanical ventilation, extra-corporeal membrane oxygenator (ECMO), or extubated.
  • Recipient Mortality at 12 Months [ Time Frame: 12 months ]
    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 ]
    Bronchiolitis Obliterans Syndrome (BOS) free graft survival at 12 months is being used as a secondary outcome.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2012)
  • 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.
  • Bronchiolitis Obliterans Syndrome (BOS) free graft survival. [ Time Frame: 12 Months ]
    Bronchiolitis Obliterans Syndrome (BOS) free graft survival at 12 months is being used as a sencondary outcome.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability
Official Title  ICMJE Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability
Brief Summary 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.
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: Treatment
Condition  ICMJE
  • Emphysema
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Cystic Fibrosis
  • Pulmonary Fibrosis
  • Bronchiectasis
  • Sarcoidosis
  • Pulmonary Hypertension
  • Alpha-1 Antitrypsin Deficiency
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Ex-vivo lung perfusion (EVLP) 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.
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 Completed
Actual Enrollment  ICMJE
 (submitted: March 21, 2018)
24
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2012)
10
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, 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 NCT01615484
Other Study ID Numbers  ICMJE UNC-002 Vitrolife
1UM1HL113115-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE
  • Duke University
  • National Heart, Lung, and Blood Institute (NHLBI)
  • 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 March 2018

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