Platelet Activation Affecting the Rate of Vascular Access Patency

Platelet Activation Affecting the Rate of Vascular Access Patency; Single Center, Prospective Observational Study

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.

Study Overview

• Status: Recruiting
• Conditions: Platelet Activation; Hemodialysis Fistula Thrombosis
• Intervention / Treatment: Biological: platelet activation factors

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Korea, Republic of
  • Non US/Canada
    • Seoul, Non US/Canada, Korea, Republic of, 02841
      • Recruiting
      • Korea University Anam Hospital
      • Contact: Jun Gyo Gwon, MD. PhD.; Phone Number: +82 10 3270 2137; Email: doctorgjg@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vascular access primary patency	Time from vascular access creation until hemodialysis related procedure	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vascular access secondary patency	Time from vascular access creation until hemodialysis failure	1 month

Collaborators and Investigators

• Sponsor: Korea University Anam Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Pathological Conditions, Anatomical; Fistula; Thrombosis
• Other Study ID Numbers: KoreaUAnamH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) cannot be shared with other researchers as it is the patient's medical information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No