Computer-generated randomized lists will be drawn up before the onset of the study using a permuted block design, under the responsibility of the Clinical Research Unit (Unité Aide Méthodologique à la Recherche Clinique, AP-HM, France). Randomization (1:1 allocation ratio) will be stratified by center (n = 16) and the number of kidneys per donor (two modalities, one or two). Randomization is centralized, web-based and accessible 24 h a day according to the allocation list. A randomization number will be allocated to each patient. The intensivist and the nurse in charge of the donor with a beating heart will be blinded regarding the allocation of treatment (preparation by an intensive care unit (ICU) nurse or a clinician not in charge of the donor). The statistician, the transplanted patients and the clinicians in charge of the transplanted patient will all be blinded concerning the treatment allocation.
Do you have any questions about this protocol?
Post your question to gather feedback from the community. We will also invite the authors of this article to respond.