Clinical trial NCT01365429: Novel Lung Trial: Normothermic Ex Vivo Lung Perfusion (Evlp) As An Assessment Of Extended/Marginal Donor Lungs
Official title: Novel Lung Trial: Normothermic Ex Vivo Lung Perfusion (Evlp) As An Assessment Of Extended/Marginal Donor Lungs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Transplant
Keywords: Lung Transplant, Transplantation Lung
Lead sponsor: XVIVO Perfusion
Sponsor class: INDUSTRY
First posted: 2011-06-03
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PAS Study Primary Endpoint
timeFrame: 3 Years
measure: PMA Study Primary Endpoint
timeFrame: 72hrs and Survival
Secondary outcomes:
measure: PMA Secondary Endpoints
timeFrame: 3 Years
measure: PAS Secondary Endpoint:
timeFrame: 5 Years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Gainesville
country: United States
facility: University of Florida-Gainesville
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford
state: Michigan
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Centre
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: XVIVO Perfusion, Inc
name: Jaya Tiwari, BS, CCRP
role: STUDY_DIRECTOR
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