Polyacrylic acid-polyvinylpyrrolidone complex for achieving hemostasis after hemodialysis: study protocol for an open-label crossover randomized controlled trial (PAA-PVP study).

Background: Achieving rapid and secure hemostasis of the vascular access point is important for patients undergoing maintenance hemodialysis (HD). We developed a polyacrylic acid-polyvinylpyrrolidone (PAA-PVP) complex that absorbs moisture such as blood or sterilizing solution, forms a hydrogel, and adheres to the body's surface, thereby exerting a powerful hemostatic effect. This study aims to compare the effect of PAA-PVP complex versus a conventional non-woven fabric pad on hemostasis at the needle puncture vascular access site in patients on HD.

Methods: This open-label crossover randomized controlled trial will include 50 participants who undergo thrice-weekly HD. Participants in whom hemostasis requires more than 10 min by compression using a conventional pad or who have a severe skin problem at the needle puncture vascular access site will be excluded from the study. Participants will be randomized in a 1:1 ratio to receive either the PAA-PVP complex or conventional pads. Three consecutive weekly hemostatic tests will be performed at 11, 9, 7, 5, 3, and 1 min. The study will employ an individual 3+3 design in which participants in whom hemostasis is achieved in all three sessions in a week will be challenged to a shorter time in the three sessions of the next week. Those in whom hemostasis is achieved in two of three sessions will be tested at the same time point in the three sessions of the next week. The study treatment will be terminated if hemostasis is achieved in only one or none of the sessions, and the minimum time with three consecutive successes will be recorded as the hemostasis time. The primary endpoint, the hemostasis time on the arterial side of the vascular access, will be analyzed using mixed-effect models for repeated measures and include the hemostatic technique and group, period, and individual effects as covariates.

Discussion: The study will provide evidence on whether the PAA-PVP complex reduces hemostasis time of the vascular access compared to conventional pad in patients on HD.

Trial Registration: jRCTs032220597 (Japan Registry of Clinical Trials; registered on January 30, 2023, https://jrct.niph.go.jp/latest-detail/jRCTs032220597 ).