What is the clinical evidence from this study?

Study design: Observational. Population: Continuous renal replacement therapy (CRRT) (n=101). Intervention: Nafamostat mesilate vs. Unfractionated heparin. Primary outcome: Bleeding complications during CRRT (OR 0.09, p=0.04).

January 1, 2016Open Access

Comparison of Nafamostat Mesilate and Unfractionated Heparin as Anticoagulants during Continuous Renal Replacement Therapy

Key Result

Nafamostat mesilate significantly reduced the risk of bleeding complications compared to unfractionated heparin during continuous renal replacement therapy (OR 0.09, p=0.04).

Study Design

Type

Observational (n=101)

Multicenter

Structured PICO

Does nafamostat mesilate reduce bleeding complications in adult patients requiring continuous renal replacement therapy compared to unfractionated heparin?

Population

101 adult patients undergoing continuous renal replacement therapy in an intensive care unit, retrospectively analyzed to compare bleeding risks between nafamostat mesilate and unfractionated heparin.

Exposure

Nafamostat mesilate (NM) as a regional anticoagulant during CRRT. Initial dose 20 mg/h, adjusted to target an activated clotting time (ACT) of 150 seconds.

Comparator

Unfractionated heparin (UFH) as an anticoagulant during CRRT. Initial dose 400 IU/h, adjusted to target an activated clotting time (ACT) of 150 seconds.

Outcome

Risk of bleeding complications during CRRT (defined as administration of ≥2 units of red blood cells or a decrease in hemoglobin of ≥2 g/dl).safety

Nafamostat mesilate may be a safer anticoagulant alternative to unfractionated heparin during continuous renal replacement therapy, as it is associated with a significantly lower risk of bleeding complications without compromising filter life.

Main Result

Odds Ratio: 0.09

Absolute Event Rate: 3.3% vs 27%

p-value: p=0.04

Limitations

Retrospective observational design with potential for bias and confounding
Single-center study lacking sufficient statistical power for generalization
Inability to collect information on factors affecting filter life (filter type, fluid volume, catheter location)
Inability to collect pre-CRRT antithrombin III levels
Study only demonstrates association, not causality

Abstract

PURPOSE: Nafamostat mesilate (NM) can be used as a regional anticoagulant for continuous renal replacement therapy (CRRT). The primary aim of this study was to assess the association of the use of NM with risk of bleeding complications and compare it with the use of unfractionated heparin (UFH). METHODS: We conducted a single-center retrospective observational study. We included adult patients who required CRRT in our intensive care unit from 2011 to 2013. The primary outcome was the risk of bleeding complications during CRRT and the secondary outcome was filter life for the first filter of CRRT. RESULTS: We included 101 patients (76 with NM, 25 with UFH). Among the 101 patients, use of NM tended to be associated with lower risk of bleeding complications (6.6% vs. 16%; odds ratio, 0.37; p = 0.16). Propensity score matching generated 30 patients with NM and 15 patients with UFH with well-balanced baseline characteristics. Among the propensity score-matched cohorts, use of NM was significantly associated with decreased risk of bleeding complications (3.3% vs. 27%; odds ratio, 0.09; p = 0.04). In multivariate logistic analysis using the inverse probability of treatment weighting for sensitive analysis, the use of NM was independently associated with reduced risk of bleeding complications (p = 0.02). The median filter life was not significantly different for patients with NM and patients with UFH (25.5 hours vs. 30.5 hours, p = 0.16). CONCLUSIONS: In our retrospective analysis, the use of NM as an anticoagulant during CRRT was associated with decreased incidence of bleeding complications compared with the use of UFH.

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