A nonrandomized open-label phase 2 trial of nonischemic heart preservation for human heart transplantation.

ABSTRACT: Pre-clinical heart transplantation studies have shown that ex vivo non-ischemic heart preservation (NIHP) can be safely used for 24 h. Here we perform a prospective, open-label, non-randomized phase II study comparing NIHP to static cold preservation (SCS), the current standard for adult heart transplantation. All adult recipients on waiting lists for heart transplantation were included in the study, unless they met any exclusion criteria. The same standard acceptance criteria for donor hearts were used in both study arms. NIHP was scheduled in advance based on availability of device and trained team members. The primary endpoint was a composite of survival free of severe primary graft dysfunction, free of ECMO use within 7 days, and free of acute cellular rejection ≥2R within 180 days. Se

SUBMITTER: Nilsson J 

PROVIDER: S-EPMC7293246 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature