Synergistic action of heparin and fluid-stopping device in reducing air embolism and hemodialysis clotting: Early results from a randomized trial

Background: Entry of air into the extracorporeal circuit and inappropriate anticoagulation are significant factors associated with clotting. Even with systemic heparination, microbubbles can be implicated as sites for thrombosis and accelerate heparin metabolism. Fluid Stop devices, which prevent fluid from flowing during line drainage, have been shown potentially to decrease air embolism and improve hemostasis within circuits, but there is no concrete evidence available regarding simultaneous heparin use. Objectives: The objective of this trial was to determine whether the use of systemic heparin and a portable fluid stop device can decrease air embolism and clotting within hemodialysis circuits compared with traditional infusion sets. Anticoagulation stability, risk of bleeding, and patient satisfaction were also measured. Methods: In this prospectively conducted single-center randomized controlled trial, 80 hemodialysis patients receiving maintenance hemodialysis were randomly assigned either to a control group with standard infusion sets or an observation group with fluid-stopping sets and all receiving standard heparin doses. A total of 800 hemodialysis sessions were conducted prospectively with observation for air bubble entrance, line draining, and clotting. Secondary endpoints included ACT variability, satisfaction rates, and instances of bleeding complications. Results: A significantly lower number of line emptying procedures (3 vs. 24; 5.0% vs. 27.5%), air bubble entries (4 vs. 28; 7.5% vs. 32.5%), and clotting incidents (2 vs. 12; 2.5% vs. 22.5%) were seen in the observation group compared with controls (P < 0.01). The stability of ACT values with smaller ranges of fluctuation was better in the observation group. Scores on satisfaction were higher, and there were no complications seen with bleeding. Conclusion: Findings from these preliminary studies indicate that fluid-stopping devices may potentially improve heparin efficacy by preventing air embolism and clotting with no loss of safety. Based on these preliminary findings, larger multicenter trials are needed.