Platelet Activation Affecting the Rate of Vascular Access Patency

NCT05165797 | Unknown

• 1 other identifier: KoreaUAnamH
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In the case of cardiovascular diseases such as coronary artery disease, cerebrovascular disease, and peripheral arterial disease, there are many studies that the use of antiplatelet agents is very helpful in improving the vascular patency rate, but there are not many studies on the use of antiplatelet agents in the dialysis approach. The basis for use is insufficient. There is a lack of research on whether maintaining a state in which platelet activation is suppressed is helpful in improving dialysis access patency. Therefore, we conducted this study to determine whether the degree of platelet activation affects the patency of vascular access.

Conditions

Platelet Activation; Hemodialysis Fistula Thrombosis

Outcome Measures

Primary Outcomes (1)

• Vascular access primary patency

  Time from vascular access creation until hemodialysis related procedure

  1 month

Secondary Outcomes (1)

• Vascular access secondary patency

  1 month

Interventions

platelet activation factors BIOLOGICAL

platelet activation factors of subject blood

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing dialysis access route formation for the purpose of hemodialysis at this institution

You may qualify if:

• Patients 19 years of age or older who are undergoing hemodialysis during renal replacement therapy
• Patients undergoing arteriovenous fistula formation and hemodialysis to the affected area
• Patients who have the ability and willingness to consent to participate in the clinical study, have signed the consent form in accordance with the appropriate procedures, and can visit and participate in the clinical study as planned

You may not qualify if:

• Patients who failed to start hemodialysis with an arteriovenous fistula within 3 months
• Patients who have had stent implantation or surgery during the study period due to cardiovascular disease
• Patients with severe hepatic impairment
• Patients with coagulopathy and liver disease associated with clinically significant bleeding risk
• Patients with clinically significant bleeding or bleeding risk
• Patients who underwent artificial heart valve replacement requiring anticoagulant administration
• Patients with pulmonary embolism who are hemodynamically unstable or require thrombolysis or pulmonary embolization.
• Pregnant and lactating women

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

Korea university anam hospital

Seoul, Non US/Canada, 02841, South Korea

RECRUITING

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 21, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: July 1, 2022
• Last Updated: December 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)