The INSPIRE International Lung Trial with the Organ Care System Technology (OCS™)

Abstract

Purpose INSPIRE Trial is an international, FDA pivotal trial to assess the clinical efficacy and safety of OCS™ device to preserve, recruit and assess the donor lungs for transplantation as compared to current cold storage technique. Methods and Materials INSPIRE is a prospective, international, multi-center, randomized controlled trial comparing preservation of donor lungs using OCS-Lung perfusion device (Treatment Group) to Cold flush and storage (Control Group). A total of 264 primary lung transplant recipients will be randomized into the trial. Donor Inclusion Criteria: age Results Primary study endpoint is a composite of patient and graft survival at day 30 post transplantation, and incidence of ISHLT Primary Graft Dysfunction (PGD) Grade 3 at 72 hours post-transplantation. Secondary Endpoints: Incidence of ISHLT Primary Graft Dysfunction Grade 3 at 72 hours post-transplantation; Incidence of ISHLT Primary Graft Dysfunction Grade 2 or 3 at 72 hours post-transplantation; Patient survival at day 30; Graft survival at day 30. Other Endpoints: PGD score at T0, T24, and T48 hours; duration of invasive mechanical ventilation; length of post transplant ICU stay; length of post-transplant hospital stay; & additional hospital admission post initial discharge. Conclusions To-date 60 patients were transplanted in the trial. We will report the interim results at the late breaking clinical trial session at ISHLT 2013.