Platelet Activation Affecting the Rate of Vascular Access Patency

Platelet Activation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05165797
• Other study ID #: KoreaUAnamH
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: December 2021
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Hemodialysis Fistula Thrombosis
• Platelet Activation
• Thrombosis

Intervention

Biological:
• platelet activation factors
platelet activation factors of subject blood

Locations

Country	Name	City	State
Korea, Republic of	Korea university anam hospital	Seoul	Non US/Canada

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular access primary patency	Time from vascular access creation until hemodialysis related procedure	1 month
Secondary	Vascular access secondary patency	Time from vascular access creation until hemodialysis failure	1 month