Cold ischemia time, the period during which a donated kidney is kept cold outside the body between its removal from the donor and its transplantation into the recipient, is one of the main modifiable factors influencing how quickly and how well a transplanted kidney starts to work and how long it lasts. In France, kidneys are usually transported between hospitals by ambulance, car, train or plane, which exposes the graft to traffic, scheduling and coordination delays. Autonomous drones could offer a fast, dedicated and predictable alternative. A human kidney was successfully transplanted after drone transport in the United States in 2019, but no transplantation after drone transport of an organ has yet been reported in Europe.
The RAfALREIN study is a pilot study designed to assess the safety and feasibility of transporting deceased-donor kidneys by autonomous drone between the Centre Hospitalier Départemental Vendée in La Roche-sur-Yon (procurement site) and Nantes University Hospital (transplantation site), within a dedicated medical air corridor subject to authorisation by the French civil aviation authority. Five adult patients will receive a kidney that has been transported by drone. Apart from the mode of transport of the graft, organ procurement, preservation, transplantation, treatments and follow-up are carried out according to usual care, with no additional examination required by the study.
The main outcome is the absence of delayed graft function, defined as no need for dialysis during the first week after transplantation. Cold ischemia time, transport time, temperature and vibrations during transport, transport costs, events preventing, delaying or interrupting drone missions, and adverse events up to 30 days after transplantation are also recorded. Participants are followed for 12 months after transplantation as part of routine care.
Study hypothesis: transport of kidney grafts by autonomous drone between two hospitals is safe, does not impair early graft function and is operationally feasible in real conditions, thereby supporting the design of a larger multicentre study.