Skip to main content
. 2022 Mar 21;35:10258. doi: 10.3389/ti.2022.10258

TABLE 5.

Ongoing clinical trials.

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.