Drone Transport of Deceased-Donor Kidney Grafts Between Two French Hospitals Before Transplantation: a Pilot Safety Study

NCT07851571 | Not Yet Recruiting

• 1 other identifier: RC26_0328
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Kidney Failure, Chronic; Kidney Transplantation; Delayed Graft Function; Cold Ischemia

Keywords

Unmanned Aerial Devices; Drone; Organ transport; Tissue and Organ Procurement; Organ Preservation; Cold Ischemia; Kidney graft; Deceased donor; Hypothermic machine perfusion; Static cold storage; Beyond visual line of sight flight; Medical air corridor; Transplantation logistics

Outcome Measures

Primary Outcomes (1)

• 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.

  From transplantation (day 0) to day 7 post-transplantation

Secondary Outcomes (7)

• Cold ischemia time

  Day 0 (from donor aortic cross-clamping to graft reperfusion in the recipient)

• Transport duration

  Day 0 (from departure of the graft from the procurement operating room to arrival at the transplantation operating room)

• Temperature during transport

  Day 0 (continuous recording throughout the drone mission)

• Vibrations during transport

  Day 0 (continuous recording throughout the drone mission)

• Budget impact of drone transport

  At the end of the study (after the last drone mission)

Study Arms (1)

Drone-transported kidney graft

EXPERIMENTAL

Adult recipients transplanted at Nantes University Hospital with a deceased-donor kidney procured at CHD Vendée (La Roche-sur-Yon) and transported to Nantes by autonomous drone. Procurement, preservation (static cold storage or hypothermic machine perfusion), transplantation, immunosuppression and 12-month follow-up are performed according to standard care. If the drone cannot take off or the mission is interrupted, the graft is transferred by conventional transport and the recipient is not included; the mission is recorded for the transport safety analysis.

Other: Kidney graft transport by autonomous unmanned aircraft (drone) between the procurement and transplantation centres

Interventions

Kidney graft transport by autonomous unmanned aircraft (drone) between the procurement and transplantation centres OTHER

After 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.

Drone-transported kidney graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Donor criteria: donor aged 18 years or older, brain-dead donor or controlled donation after circulatory death

You may not qualify if:

• Adult under guardianship or curatorship
• Pregnant or breastfeeding woman

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: collaborator
• Agence de La Biomédecine: collaborator
• Nantes University Hospital: lead
• Delivrone SAS (drone operator): collaborator

Related Publications (10)

• Karpstein R, Brolli J, Stiegler P, Sucher R, Holzapfel F, Biberthaler P. Evaluation of the advanced air mobility potential for organ transplantation in Austria and Germany. Sci Rep. 2024 Nov 30;14(1):29782. doi: 10.1038/s41598-024-81045-2.

  PMID: 39616204 BACKGROUND

• Gilmour RG, Hoff M. Drone-Assisted Organ Transport: A Scoping Review of Clinical, Regulatory, and System Readiness. Clin Transplant. 2025 Dec;39(12):e70398. doi: 10.1111/ctr.70398.

  PMID: 41383068 BACKGROUND

• Scalea JR, Pucciarella T, Talaie T, Restaino S, Drachenberg CB, Alexander C, Qaoud TA, Barth RN, Wereley NM, Scassero M. Successful Implementation of Unmanned Aircraft Use for Delivery of a Human Organ for Transplantation. Ann Surg. 2021 Sep 1;274(3):e282-e288. doi: 10.1097/SLA.0000000000003630.

  PMID: 31663974 BACKGROUND

• Scalea JR, Restaino S, Scassero M, Blankenship G, Bartlett ST, Wereley N. An Initial Investigation of Unmanned Aircraft Systems (UAS) and Real-Time Organ Status Measurement for Transporting Human Organs. IEEE J Transl Eng Health Med. 2018 Nov 6;6:4000107. doi: 10.1109/JTEHM.2018.2875704. eCollection 2018.

  PMID: 30464862 BACKGROUND

• Sylverken AA, Owusu M, Agbavor B, Kwarteng A, Ayisi-Boateng NK, Ofori P, El-Duah P, Yeboah R, Aryeetey S, Addo Asamoah J, Ekekpi RZ, Oppong M, Gorman R, Brempong KA, Nyarko-Afriyie E, Owusu Bonsu F, Larsen-Reindorf R, Rockson Adjei M, Boateng G, Asiedu-Bekoe F, Sarkodie B, Laryea DO, Tinkorang E, Kumah Aboagye P, Nsiah Asare A, Obiri-Danso K, Owusu-Dabo E, Adu-Sarkodie Y, Phillips RO. Using drones to transport suspected COVID-19 samples; experiences from the second largest testing centre in Ghana, West Africa. PLoS One. 2022 Nov 1;17(11):e0277057. doi: 10.1371/journal.pone.0277057. eCollection 2022.

  PMID: 36318579 BACKGROUND

• Nisingizwe MP, Ndishimye P, Swaibu K, Nshimiyimana L, Karame P, Dushimiyimana V, Musabyimana JP, Musanabaganwa C, Nsanzimana S, Law MR. Effect of unmanned aerial vehicle (drone) delivery on blood product delivery time and wastage in Rwanda: a retrospective, cross-sectional study and time series analysis. Lancet Glob Health. 2022 Apr;10(4):e564-e569. doi: 10.1016/S2214-109X(22)00048-1.

  PMID: 35303465 BACKGROUND

• Debout A, Foucher Y, Trebern-Launay K, Legendre C, Kreis H, Mourad G, Garrigue V, Morelon E, Buron F, Rostaing L, Kamar N, Kessler M, Ladriere M, Poignas A, Blidi A, Soulillou JP, Giral M, Dantan E. Each additional hour of cold ischemia time significantly increases the risk of graft failure and mortality following renal transplantation. Kidney Int. 2015 Feb;87(2):343-9. doi: 10.1038/ki.2014.304. Epub 2014 Sep 17.

  PMID: 25229341 BACKGROUND

• van de Laar SC, Lafranca JA, Minnee RC, Papalois V, Dor FJMF. The Impact of Cold Ischaemia Time on Outcomes of Living Donor Kidney Transplantation: A Systematic Review and Meta-Analysis. J Clin Med. 2022 Mar 15;11(6):1620. doi: 10.3390/jcm11061620.

  PMID: 35329945 BACKGROUND

• Scalea JR, Restaino S, Scassero M, Bartlett ST, Wereley N. The final frontier? Exploring organ transportation by drone. Am J Transplant. 2019 Mar;19(3):962-964. doi: 10.1111/ajt.15113. Epub 2018 Oct 4. No abstract available.

  PMID: 30203436 BACKGROUND

• - Gavzy SJ, Scalea JR. Organ transportation innovations and future trends. Curr Transplant Rep. 2022;9:143-147.

  BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Delayed Graft Function

Interventions

Unmanned Aerial Devices

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aircraft; Aviation; Transportation; Technology, Industry, and Agriculture

Central Study Contacts

Julien Branchereau, MD PhD

CONTACT

+33 2 40 08 39 10; julien.branchereau@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 1, 2026
• Study Start (Estimated): January 15, 2027
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share