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Phase 2, Multicenter, Open-Label Study to Measure the Safety of Extending Preservation and Assessment Time of Donor Lungs Using Normothermic Ex Vivo Lung Perfusion and Ventilation (EVLP) as Administered by the Sponsor Using the Toronto EVLP System This

General Information

Age Group

Adult

Status

Active

Protocol Number

PXUS 14-001

Background Information

Because there are not enough acceptable donor lungs for patients that need transplants, researchers are testing another way to preserve and screen donor lungs. The purpose of this research study is to test if lungs that are not considered standard donor organs can meet the criteria used for standard donor organs after being pumped and tested ex-vivo (out of the donor’s body).

National Clinical Trial (NCT) identifier on clinicaltrials.gov: NCT02234128

Offered At

Inova Heart and Vascular Institute
Advanced Lung Disease and Transplant Clinic
3300 Gallows Road, Falls Church, VA 22042

Principal Investigator

A. Whitney Brown, MD

Eligibility Information

  • Male or female patients
  • All patients, 18 years of age or older
  • Patient already on or added to the active waiting list for a single or bilateral lung transplant
  • Patient or patient's representative provides informed consent for participation in the study at the time of study commencement or time of listing for transplant
  • Patient or patient's representative reconfirms informed consent for the study on the day of lung transplant

Ineligibility Information

  • Patients listed for same-side lung re-transplantation
  • Patients listed for multiple organ transplantation including lung and any other organ
  • Patients listed for live donor lobar transplant
  • Patients with HIV, active Hepatitis B/C, or Burkholderia Cepacia
  • Patients not initially consented into the study prior to the time of lung transplant
  • Patients in the ICU at the time of initial lung offer requiring mechanical ventilation, ECMO or other Extracorporeal life support (ECLS).