Polyacrylic acid-polyvinylpyrrolidone complex for achieving hemostasis after hemodialysis: study protocol for an open-label crossover randomized controlled trial (PAA-PVP study)
Abstract 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 hydro...
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2025-05-01
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| Online Access: | https://doi.org/10.1186/s13063-025-08877-9 |
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| author | Ryohei Terashima Mototsugu Tanaka Atsushi Hashimoto Daiki Omori Takahiro Tanaka Haruna Miyazawa Masahiro Ishizawa Yoshihiko Tomita Tomoko Ito Yoshiyuki Koyama Kokichi Saito Suguru Yamamoto Shin Goto Ichiei Narita |
| author_facet | Ryohei Terashima Mototsugu Tanaka Atsushi Hashimoto Daiki Omori Takahiro Tanaka Haruna Miyazawa Masahiro Ishizawa Yoshihiko Tomita Tomoko Ito Yoshiyuki Koyama Kokichi Saito Suguru Yamamoto Shin Goto Ichiei Narita |
| author_sort | Ryohei Terashima |
| collection | DOAJ |
| description | Abstract 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 ). |
| format | Article |
| id | doaj-art-93cf85fb7c0c4227965c6f18c398bcd7 |
| institution | DOAJ |
| issn | 1745-6215 |
| language | English |
| publishDate | 2025-05-01 |
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| spelling | doaj-art-93cf85fb7c0c4227965c6f18c398bcd72025-08-20T03:08:44ZengBMCTrials1745-62152025-05-012611810.1186/s13063-025-08877-9Polyacrylic acid-polyvinylpyrrolidone complex for achieving hemostasis after hemodialysis: study protocol for an open-label crossover randomized controlled trial (PAA-PVP study)Ryohei Terashima0Mototsugu Tanaka1Atsushi Hashimoto2Daiki Omori3Takahiro Tanaka4Haruna Miyazawa5Masahiro Ishizawa6Yoshihiko Tomita7Tomoko Ito8Yoshiyuki Koyama9Kokichi Saito10Suguru Yamamoto11Shin Goto12Ichiei Narita13Clinical and Translational Research Center, Niigata University Medical and Dental HospitalClinical and Translational Research Center, Niigata University Medical and Dental HospitalClinical and Translational Research Center, Niigata University Medical and Dental HospitalClinical and Translational Research Center, Niigata University Medical and Dental HospitalClinical and Translational Research Center, Niigata University Medical and Dental HospitalClinical and Translational Research Center, Niigata University Medical and Dental HospitalClinical and Translational Research Center, Niigata University Medical and Dental HospitalClinical and Translational Research Center, Niigata University Medical and Dental HospitalObara Hospital Research InstituteObara Hospital Research InstituteDepartment of Internal Medicine, Itoigawa General HospitalDivision of Clinical Nephrology and Rheumatology, Niigata University Graduate School of Medical and Dental SciencesDivision of Clinical Nephrology and Rheumatology, Niigata University Graduate School of Medical and Dental SciencesDivision of Clinical Nephrology and Rheumatology, Niigata University Graduate School of Medical and Dental SciencesAbstract 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 ).https://doi.org/10.1186/s13063-025-08877-9Arteriovenous fistulaArteriovenous graftBleeding timeClotting timeEnd-stage kidney diseaseEnd-stage renal disease |
| spellingShingle | Ryohei Terashima Mototsugu Tanaka Atsushi Hashimoto Daiki Omori Takahiro Tanaka Haruna Miyazawa Masahiro Ishizawa Yoshihiko Tomita Tomoko Ito Yoshiyuki Koyama Kokichi Saito Suguru Yamamoto Shin Goto Ichiei Narita Polyacrylic acid-polyvinylpyrrolidone complex for achieving hemostasis after hemodialysis: study protocol for an open-label crossover randomized controlled trial (PAA-PVP study) Trials Arteriovenous fistula Arteriovenous graft Bleeding time Clotting time End-stage kidney disease End-stage renal disease |
| title | Polyacrylic acid-polyvinylpyrrolidone complex for achieving hemostasis after hemodialysis: study protocol for an open-label crossover randomized controlled trial (PAA-PVP study) |
| title_full | Polyacrylic acid-polyvinylpyrrolidone complex for achieving hemostasis after hemodialysis: study protocol for an open-label crossover randomized controlled trial (PAA-PVP study) |
| title_fullStr | Polyacrylic acid-polyvinylpyrrolidone complex for achieving hemostasis after hemodialysis: study protocol for an open-label crossover randomized controlled trial (PAA-PVP study) |
| title_full_unstemmed | Polyacrylic acid-polyvinylpyrrolidone complex for achieving hemostasis after hemodialysis: study protocol for an open-label crossover randomized controlled trial (PAA-PVP study) |
| title_short | Polyacrylic acid-polyvinylpyrrolidone complex for achieving hemostasis after hemodialysis: study protocol for an open-label crossover randomized controlled trial (PAA-PVP study) |
| title_sort | polyacrylic acid polyvinylpyrrolidone complex for achieving hemostasis after hemodialysis study protocol for an open label crossover randomized controlled trial paa pvp study |
| topic | Arteriovenous fistula Arteriovenous graft Bleeding time Clotting time End-stage kidney disease End-stage renal disease |
| url | https://doi.org/10.1186/s13063-025-08877-9 |
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