Blood purification · 2026
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).
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Moranne Olivier, Gerbal Marion, Chkair Sihame, Cariou Sylvain, Prouvot Julien, Reboul Pascal, Pambrun Emilie, Chevallier Thierry, Messikh Zihad
Аннотация
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.
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.