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

Authors
Journal
The Journal of Heart and Lung Transplantation
1053-2498
Publisher
Elsevier
Volume
32
Issue
4
Identifiers
DOI: 10.1016/j.healun.2013.01.020
Disciplines
  • Medicine

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 <65, normal gas exchange at time of final acceptance of donor lung, and no active primary pulmonary disease. Recipient Inclusion Criteria: age ≥ 18 years old; registered male or female primary double lung transplant candidate; & signed written informed consent for the trial. Donor Exclusion Criteria: positive serology; presence of moderate to severe traumatic lung injury; & presence of confirmed active pneumonia. Recipient Exclusion Criteria: prior solid organ or bone marrow transplant; single lung recipient; chronic use of renal dialysis or diagnosed of chronic renal dysfunction; and multi-organ transplant recipient. 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.

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