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Novel Lung Trial: Normothermic Ex Vivo Lung Perfusion (Evlp) As An Assessment Of Extended/Marginal Donor Lungs

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ClinicalTrials.gov Identifier: NCT01365429
Recruitment Status : Active, not recruiting
First Posted : June 3, 2011
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
XVIVO Perfusion

Tracking Information
First Submitted Date  ICMJE June 2, 2011
First Posted Date  ICMJE June 3, 2011
Last Update Posted Date March 7, 2018
Study Start Date  ICMJE May 2011
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2015)
  • PAS Study Primary Endpoint [ Time Frame: 3 Years ]
    The primary end point is a co-primary endpoint comparing survival rates and rates of grade 3 PGD at 72 hours with success if and only if both endpoints are met. Treatment Group (T) = EVLP transplant subjects Control Group (C) = standard transplant subjects Co-Primary Endpoints: Endpoint #1: Survival of T is non-inferior to C Ho: C - T ≥ M1 (T is inferior to the control by M1 or more) Ha: C - T < M1 (T is inferior to the control by less than M1) where M1 = 0.12 Endpoint #2: Rate of grade 3 PGD at 72 hours for T is non-inferior to the rate for C Ho: C - T ≥ M2 Ha: C - T < M2 where M2 = 0.12
  • PMA Study Primary Endpoint [ Time Frame: 72hrs and Survival ]
    The primary end point is non-inferiority of the 3-year survival rate of the EVLP group as compared to 3-year survival rate of the control group. Ho: C - T ≥ M3 (T is inferior to the control by M3 or more) Ha: C - T < M3 (T is inferior to the control by less than M3) where M3 = 0.12
Original Primary Outcome Measures  ICMJE
 (submitted: June 2, 2011)
30 Day Mortality [ Time Frame: 30 Days ]
Mortality at 30 days post transplant.
Change History Complete list of historical versions of study NCT01365429 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2017)
  • PMA Secondary Endpoints [ Time Frame: 3 Years ]
    Primary Lung Graft Dysfunction (PGD) is an indicator for significant morbidity The PMA secondary endpoints are as follows:
    • FEV1 at 3 mos, 6 mos, 9 mos, and 1 yr
    • PGD score at 24 and 48 hrs
    • ICU LOS
    • Hospital LOS
    • Use of ECMO due to lung function post transplant
    • Duration of mechanical ventilation post transplant
    • Quality of Life and functional status at one year
  • PAS Secondary Endpoint: [ Time Frame: 5 Years ]
    Quality of Life measured by functional status, physical capability, and employment limitations.
    • Episodes of rejection per UNOS registry
    • FEV1 at 1, 2, 3, 4, and 5 years
Original Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2011)
  • PGD Scores at 0,24,and 72 hours [ Time Frame: 72 hours ]
    Primary Lung Graft Dysfunction (PGD) is an indicator for significant morbidity and mortality after lung transplantation. PGD is assessed at 0, 24 and 72 hours post operative by the Surgeon using the following scale/categories 0-1, 2, and 3, refer to Appendix III. The 72 hour assessment is analyzed as a secondary objective.
  • Intensive Care Unit Stay [ Time Frame: 30 Days ]
    Length of ICU stay post transplant
  • Day 7 Ventilator/ECMO Status [ Time Frame: 7 Days ]
    Ventilator status and extra-corporeal membrane oxygenator (ECMO) free is assessed seven days after transplant.
  • 12 Month Survival [ Time Frame: 12 Months ]
    12 month subject's survival status shall be evaluated.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Novel Lung Trial: Normothermic Ex Vivo Lung Perfusion (Evlp) As An Assessment Of Extended/Marginal Donor Lungs
Official Title  ICMJE Novel Lung Trial: Normothermic Ex Vivo Lung Perfusion (Evlp) As An Assessment Of Extended/Marginal Donor Lungs
Brief Summary Human donor lungs that do not meet the standard clinical criteria for donor lung utilization but fit into the study inclusion criteria will be retrieved from the donor using current donor lung retrieval techniques.
Detailed Description These lungs will be brought to the study transplant center to be re-assessed by the transplant team. The lungs will be physiologically assessed during ex vivo perfusion with Steen Solution. Perfusion of these lungs will be performed using Steen solution with the addition of methylprednisolone, heparin and antibiotics. With respect to the decision of lung utilization those organs with a delta pO2 (Δ pO2 = Pulmonary vein pO2 - pulmonary artery pO2) during ex vivo perfusion assessment > 350mmHg, good lung compliance, and a favorable opinion of the transplant surgeon will be considered transplantable. Lungs will be excluded for transplantation: if the Δ pO2 is less than 350mmHg or if they demonstrate >10% deterioration in any of the following functional parameters: pulmonary vascular resistance (PVR), dynamic compliance or airway pressures. Lungs will also be excluded if they are deemed unsuitable based on the clinical judgment of the lung transplant surgeon.
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: Diagnostic
Condition  ICMJE Lung Transplant
Intervention  ICMJE Device: XPS™ with Steen Solution™
The XPS™ System is an integrated cardiac bypass system comprised of various components such as a Maquet CardioHelp centrifugal pump (K102726), the HicoVariotherm Heater/Cooler, the Hamilton C2 ICU (intensive care unit) pressure- controlled ventilator (K092148), the perfusate gas monitors, and the display monitors. The XPS™ System is responsible for housing the organ for preservation, providing the normothermic environment, and perfusing the organ with the STEEN Solution™. Donor lungs that meet inclusion criteria are placed on the XPS™ and rewarmed and perfused with STEEN Solution™ and ventilated for 3-6 hours. If the lungs meet transplant suitability, they are cooled down and transplanted into a consented recipient that meet's trial criteria.
Other Names:
  • EVLP
  • ex vivo lung perfusion
Study Arms  ICMJE
  • Experimental: EVLP Group
    EVLP Group are those recipient lung transplant patients that received donor lungs that had been placed on the XPS™ with Steen Solution™ and undergone ex-vivo lung perfusion before being transplanted.
    Intervention: Device: XPS™ with Steen Solution™
  • No Intervention: Control Group
    Control Group are those recipient lung transplant patients that receive donor lungs via conventional 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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 5, 2018)
252
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2011)
84
Estimated Study Completion Date  ICMJE December 2020
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Recipient Inclusion/Exclusion Criteria The recipient inclusion/exclusion criteria apply to patients enrolled in the control or EVLP treatment arms.

  1. Recipient Inclusion Criteria

    1. Requires single or bilateral lung transplant.
    2. Male or Female, 18 years of age or older.
    3. Subject or Subject's Representative provides a legally effective informed consent.
  2. Recipient exclusion Criteria

    1. A recipient is HIV positive.
    2. A recipient has active Hepatitis.
    3. Investigator believes that the recipient has infection that excludes them from transplant in the study.
    4. To receive multi-organ transplant.
    5. Is on hemodialysis or has chronic severe renal dysfunction. Severe renal dysfunction is defined as a glomerular filtration rate of 29 or less (mL/min/1.73m2).
    6. Is to have planned concurrent cardiac procedures.
    7. A recipient is a re-transplant. (A re-transplant is defined as a recipient having the removal and transplant of a previously transplanted lung. A recipient with a previously single lung transplant is eligible to enroll in the trial if it is for the other lung and within 6 months of previous transplant.)
    8. A recipient is on Nova Lung, ECMO, or on mechanical ventilation. (CPAP and BIPAP are not exclusionary)

Donor Inclusion/Exclusion Criteria for EVLP Assessment

  1. Donor Inclusion Criteria

    1. The Donor lung must meet the following criteria to proceed with EVLP:
    2. At the time of the clinical evaluation , the PaO2/FiO2 ≤ 300mmHg Or If PaO2/FiO2 > 30mmHg and the donor has any one or more of the following donor risk factors:

      • Multiple blood transfusions.
      • Pulmonary edema detected via CXR, bronchoscopy or palpation of lungs.
      • Donation after circulatory death donors.
      • Investigator evaluation of donor lung as "unsuitable" for standard criteria for lung transplant. List reason for "unsuitable" determination.
  2. Donor Exclusion Criteria

    1. Lung has significant pneumonia and/or persistent purulent secretions on bronchoscopy as determined by investigator.
    2. Donor has known significant aspiration of gastric contents within the lung.
    3. Donor lung has significant mechanical lung injury or trauma determined by chest x-ray, bronchoscopy, CT Scan or visual inspection.
    4. Donor lung has active infectious disease such as HIV, Hepatitis B or C, HTLV or Syphilis. Note: This information is not available at the start of EVLP. Therefore this criteria can be assessed during or post EVLP, but prior to transplant.

Donor Inclusion/Exclusion Criteria for Transplant Suitability after EVLP

  1. Donor Inclusion Criteria for Transplant Suitability

    1. Surgeon must be clinically satisfied with the lung evaluation (i.e.) overall improvement, if not, the reason for refusal must be listed.
    2. Stability or improvement of other lung function parameters during EVLP perfusion - PVR, Compliance, Airway Pressures.
    3. Two delta PO2 greater than 350 mmHg, if two delta PO2 mm Hg are not met than three out of four of the following parameters must be present:

      • One delta PO2 of > 350 or absolute PO2 of > 400.
      • Chest x-ray findings with absence or improvement of pulmonary edema/infiltrates
      • Compliance static (greater than 35 single and greater than 60 for a double)
      • Absence of consolidation by palpation
  2. Donor Exclusion Criteria for Transplant Suitability after EVLP

    1. All delta PO2 (s) are less than 350 mmHg (measured with a FiO2 set at 1.0) or all absolute PO2s are less than 400.
    2. Overall greater than 10-15% Functional deterioration of other lung function across all parameters (PVR, Compliance, PawP) with chest x-ray findings showing deterioration.
    3. Donor lung positive for infectious diseases such as HIV, Hepatitis B or C, or Syphilis.

Note: This information is not available until at the start of EVLP. Therefore this criteria can be assessed during or post EVLP, but prior to transplant.

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 NCT01365429
Other Study ID Numbers  ICMJE VSS-NA-001, XVO-NA-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party XVIVO Perfusion
Study Sponsor  ICMJE XVIVO Perfusion
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jaya Tiwari, BS, CCRP XVIVO Perfusion, Inc
PRS Account XVIVO Perfusion
Verification Date March 2018

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