Intermittent hemodialysis with regional citrate anticoagulation vs. priming heparin and pre-dilution HDF in patients at Risk Of Bleeding in Nephrology (the ROBIN randomized control trial)

Introduction: This single center randomized controlled trial (NCT 03562754) compared pre-diluted IHDF (PIHDF) without systemic anticoagulation and the Prometheus system with regional citrate anticoagulation (IHD-RCA) in high-bleeding-risk patients. Methods: IHD-RCA with the Prometheus® device and PIHDF with a 5008H® dialysis monitor using priming and pre-dilution HDF online (25 ml/min) were compared in a 4-hour IHD session for 60 high-bleeding-risk patients between 2019 and 2020. Bleeding risk was defined by the nephrologist. Successful hemodialysis was defined as no premature interruption of the 4-hour session. We also analyzed adequacy (KT/V), dialyzer membrane status, cost and organization from the nurse’s viewpoint. Results: 82% of patients were on chronic IHD and 41% had a fistula. Three patients in the IHD-RCA arm were excluded for early vascular access failure or persistent oral anticoagulation. No statistically significant difference was observed for the primary outcome between the two techniques (96% vs. 83%, p=0.11). With PIHDF, 2 in 5 sessions failed after 3 hours. No statistically significant difference in KT/V was observed between groups (1.69 vs. 1.61, p=0.27) but a significantly higher mean blood flow for PIHDF was reached (294 vs. 263 ml/min., p<0.001). The visual coagulation score was significantly worse for PIHDF (p<0.01). No difference in clinical tolerance was found between groups. Hospital costs were higher with IHD-RCA than PIHD, mainly due to the nurse’s workload. Conclusions Statistically, the primary outcome was not significantly different between techniques. The Prometheus device is efficient and clinically well-tolerated but PIHD is a cheaper, simpler procedure with little risk of coagulation if the session only lasts 3 hours.