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.