Intermittent Hemodialysis with Regional Citrate Anticoagulation versus 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 (NCT03562754) compared pre-diluted IHDF (PIHDF) without systemic anticoagulation and the Prometheus system with regional citrate anticoagulation (RCA) in high-bleeding-risk patients.

METHODS

Intermittent hemodialysis (IHD) with RCA (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-h IHD session for 60 high-bleeding-risk patients between 2019 and 2020. Bleeding risk was defined by a nephrologist. Successful hemodialysis was defined as no premature interruption of the 4-h session. We also analyzed adequacy (KT/V), dialyzer membrane status, cost, and organization from the nurse's viewpoint.

RESULTS

Eighty-two percent 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 h. 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 with PIHD, mainly due to the nurse's workload.

CONCLUSION

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 h.