PAA-PVP trial

JRCT ID: jRCTs032220597

Registered date:31/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic kidney disease undergoing hemodialysis
• Date of first enrollment: 31/01/2023
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Use of poly acrylic acid-poly vinylpyrrolidone for hemostasis after hemodialysis treatment.

Outcome(s)

• Primary Outcome: Minimum hemostasis time at arterial access points

Secondary Outcome

Minimum hemostasis time at venous access points
The success rate of hemostasis after 11 minute-use of poly acrylic acid-poly vinylpyrrolidone

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who meet all the inclusion criteria as below,
1. Patients who can obtain written informed consent to participate in this study based on their free will.
2. Patients who are more than 18 years old.
3. Patients undergoing regular hemodialysis treatment 3 times a week and for 3-5 hours each session using internal shunt.
4. Patients who use heparin as anti-coagulant for hemodialysis treatment
5. Patients whose bleeding time after decannulation at the end of hemodialysis treatment is 10 minutes using regular hemostasis pad and band.

Exclude criteria

Patients who meet any exclusion criteria as below.
1. Patients who participate in other clinical studies.
2. Patients who are pregnant or want pregnancy.
3. Patients who do not use internal shunt as vascular access.
4. Patients who use fingers or use band for more than 10 minutes for hemostasis after decannulation at the end of hemodialysis treatment.
5. Patients who have serious skin disease.
6. Patients who have the plan to start anti-coagulant/anti-platelet therapy
7. Patients that the investigators decide inappropriate to join the study.

Related Information

• Primary Sponsor: Yamamoto Suguru
• Source(s) of Monetary Support: TOAGOSEI CO., LTD.