TABLE 5.
NCT number | Institution | Study phase/design | Starting date–estimated primary completion date | Estimated number of enrolled patients | Study arms | Outcome measures (time frame) |
---|---|---|---|---|---|---|
NCT03687723 (41) | Hannover Medical School, Hannover, Germany | Multicenter, observational | October 2016–December 2021 | 60 | Clinical use of OCS | Primary outcome: patient survival (12 months); secondary outcomes: patient and graft survival (30 days) |
NCT03991923 (42) | UZ Leuven, Leuven, Flemish Brabant, Belgium, etc., total eight centers in Europe | Multicenter, randomized | July 2020–July 2021 | 202 | NIHP, STS | Primary outcome: mortality and graft dysfunction (30 days); secondary outcomes: mortality and graft dysfunction (time frame 12 months) |
NCT04066127 (43) | Skane University Hospital Lund, Skane, Sweden | Randomized | June 2020–December 2022 | 66 | NIHP, STS | Primary outcome: survival free of acute cellular rejection and re-transplantation (12 months); secondary outcomes: I/R-tissue injury, early allograft dysfunction, and health status |
NCT03835754 (44) | Cedars-Sinai, Stanford University, Yale New Haven Hospital, etc., total 12 centers from United States | Multicenter | June 2019–November 2020 | 48 | Clinical use of OCS, high risk donors | Primary outcome: patient survival (30 days), absence of severe PGD (24 h post heart transplant); secondary outcome: patient and graft survival (30 days), incidence of severe PGD and donor heart utilization rate (24 h post-transplant) |
NCT03831048 (45) | Stanford University, Yale New Haven Hospital, Mayo Clinic, etc., total 16 centers from United States | Multicenter, randomized | December 2019–August 2021 | 212 | DCD donors: OCS, SCS | Primary outcome: survival (6 months); secondary outcome: utilization rate (within 24 h post-transplant) |
DCD, donation after circulatory death; NIHP, non-ischemic hypothermic preservation; OCS, organ care system; PGD, primary graft dysfunction; SCS, static cold storage.