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

Protocol: 
AAAI1133
Phase: 
I

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

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.

Are you Eligible? (Inclusion Criteria)

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.

Donor Inclusion Criteria for EVLP Assessment

  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 cardiac death donors.
    • Investigator evaluation of donor lung as "unsuitable" for standard criteria for lung transplant. List reason for "unsuitable" determination.

Donor Inclusion Criteria for Transplant Suitability after EVLP

  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

Specialty Area(s)

Trial Location

Columbia University Medical Center
New York, NY 10032
United States