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.
Male or female aged 18 years or older, scheduled to receive a kidney transplant at Nantes University Hospital from a deceased donor (brain death or controlled donation after circulatory death)
Kidney graft procured at CHD Vendée (La Roche-sur-Yon) and effectively transported by drone (study population, protocol section 5.1)
Affiliation to a social security scheme
Oral consent to participate, recorded in the medical file (inclusion on the day of transplantation, day 0)
Adult under guardianship or curatorship
Pregnant or breastfeeding woman
Single group
Kidney graft transport by autonomous unmanned aircraft (drone) between the procurement and transplantation centres
Other interventionAfter standard procurement at CHD Vendée, the kidney is packaged in a refrigerated container clinically approved for graft transport (static cold storage or hypothermic machine perfusion) and flown to Nantes University Hospital by an autonomous vertical take-off and landing fixed-wing drone (RigiTech Eiger, payload up to 3 kg), operated beyond visual line of sight by Delivrone within a dedicated air corridor subject to French civil aviation (DSAC) authorisation. Temperature, three-axis vibrations (sterile sensor in contact with the graft), each transport phase duration and any incident are recorded. The graft is then transplanted according to standard surgical practice. In case of no take-off or in-flight interruption, conventional transport is used.
Absence of delayed graft function (no dialysis during the first week after kidney transplantation)
Safety of kidney graft transport by autonomous drone assessed through early graft function. Delayed graft function is defined as the need for at least one dialysis session during the first 7 days after transplantation. Results are expressed as the proportion of recipients without delayed graft function, with its exact 95% confidence interval (Clopper-Pearson method). Recipients with missing information on dialysis within 7 days are considered non-evaluable and the number of evaluable recipients is reported.
Cold ischemia time
Duration of cold ischemia of the drone-transported graft, in minutes; mean, standard deviation, median, minimum and maximum, and individual values per graft.
Transport duration
Door-to-door transport time in minutes, detailed by phase: ground transfer before flight, loading of the container into the drone, flight time, ground transfer after landing.
Temperature during transport
Mean temperature (°C) recorded inside the transport container during the mission, with minimum and maximum values.
Vibrations during transport
Mean acceleration (G) per transport and per graft along three axes, measured by a sterile accelerometer placed in contact with the graft.
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Nantes University Hospital
Lead sponsor
Centre Hospitalier Departemental Vendee
Collaborator
Delivrone SAS (drone operator)
Collaborator
Agence de La Biomédecine
Collaborator
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