Fondaparinux versus regional citrate anticoagulation in artificial liver support for patients with liver failure and high bleeding risk: A pilot randomized controlled trial.

BACKGROUND: Anticoagulation during therapeutic plasma exchange (TPE) is challenging in patients with liver failure and high bleeding risk. This pilot trial compared fondaparinux with regional citrate anticoagulation (RCA) during membrane-based TPE. METHODS: In a prospective, open-label, randomized controlled trial with blinded endpoint adjudication, 60 adults were assigned 1:1 to fondaparinux or RCA. The primary endpoint was a patient-level composite of ISTH-defined major bleeding or treatment-interrupting circuit thrombosis. Secondary outcomes included citrate accumulation, monitoring workload, procedural cost, and anti-Xa activity. RESULTS: The 60 patients underwent 187 TPE sessions. The primary endpoint occurred in 7/30 patients (23.3%) receiving fondaparinux and 9/30 (30.0%) receiving RCA (risk difference -6.7%, 95% CI -27.9-15.4; P = 0.77). Major bleeding occurred in 6.7% of patients in each group. Fondaparinux reduced blood gas measurements (3.1 vs. 9.7 per session), pump-rate adjustments (2.0 vs. 6.3), clinician contact time (23.1 vs. 42.4 min), and anticoagulation-attributable cost (RMB 247 (IQR 244-251) vs. RMB 431 (IQR 422-439); all P < 0.001). Median peak anti-Xa activity was 0.59 IU/mL, and no patient exceeded 1.0 IU/mL. CONCLUSIONS: Fondaparinux showed no statistically significant difference from RCA in the composite endpoint and reduced monitoring burden and procedural cost. These pilot findings support a larger multicenter trial; definitive non-inferiority was not established.