Vascular access management after percutaneous transluminal angioplasty using a calcium alginate sheet: a randomized controlled trial.

ABSTRACT

BACKGROUND: Management of vascular access (VA) is essential in hemodialysis (HD) patients. However, VA often fails and percutaneous transluminal angioplasty (PTA) is required. Conventional hemostasis at the puncture site is associated with complications. This study aimed to analyze the efficacy and safety of a hemostatic wound dressing made of calcium alginate at the puncture site of VA after PTA and evaluate other factors affecting hemostasis. METHODS: After PTA for VA, 200 HD patients were randomized to a calcium alginate sheet (CA) group (n = 100) or a no drug-eluting sheet (control) group (n = 100). We recorded time to hemostasis at the puncture site every 5 min, noting any complications. RESULTS: In the CA group, rates of hemostatic achievement at 5, 10, 15 and >15 min were 57, 25, 8 and 10%, respectively. In the control group, the rates were 39, 28, 14 and 19%, respectively. Rates of hemostatic achievement at 5 min were significantly higher in the CA group (P = 0.01). In logistic regression analysis, factors affecting hemostasis within 5 min were use of the CA sheet [odds ratio (OR) 2.33; 95% confidence interval (CI) 1.26-4.37], platelet count ≤100 000/µL (OR 0.19; 95% CI 0.04-0.69), number of antithrombotic tablets used per day ≥1 tablet (OR 0.50; 95% CI 0.26-0.94) and upper arm VA (OR 0.16; 95% CI 0.03-0.55). CONCLUSIONS: A CA sheet can safely reduce time to hemostasis at the puncture site after PTA, and should be considered for treating patients with a bleeding tendency.