Efficacy and Safety of Short-term Postoperative Anticoagulant Therapy to Prevente Thrombosis in Arterovenous Fistula
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 287
- Locations
- 1
- Primary Endpoint
- Blood flow of arteriovenous fistula
Study Overview
Brief Summary
Many guidelines at home and abroad advocate that arteriovenous fistula should be the first choice of permanent vascular access, but it is easy to form thrombus in a short time after arteriovenous fistula molding, resulting in internal fistula stenosis or occlusion. In this study, the investigators plan to screen the patients with arteriovenous fistula in the blood purification center of our hospital. Through the study design of random grouping and open label, the investigators will discuss the use of low molecular weight heparin or warfarin to prevent thrombosis in a short period of time after arteriovenous fistula operation. According to the research results, the investigators will understand efficacy and safety of short-term postoperative anticoagulant therapy to prevente thrombosis in arterovenous fistula.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •After AVF formation or balloon dilation surgery, there were no significant signs of oozing or bleeding at the surgical incision and operative site observed within 12-24 hours.
- •The patient is willing to accept short-term anticoagulant therapy after the surgery, bear related risks, and sign an informed consent form.
- •The patient is willing to cooperate with this study, undergo data collection related to the research, and relevant clinical examinations.
- •Exclusion Criteria.
- •Age >80 years;
- •Concurrent hematologic diseases that can affect coagulation function;
- •Concurrent comorbidities that can affect the patient's bleeding or coagulation functions, such as liver cirrhosis;
- •Concurrent active bleeding disorders, such as active gastrointestinal ulcers or active lupus;
- •History of major organ bleeding (e.g., intracranial or gastrointestinal) or surgery within the past six months;
- •Unwillingness to participate in this study.
Exclusion Criteria
- Not provided
Arms & Interventions
anticoagulant group
Patients in the anticoagulant group received low-dose subcutaneous injection of low molecular weight heparin for prevention of AVF thrombosis, starting 12-24 hours after surgery. For patients weighing less than 80kg, enoxaparin sodium 4000IU was administered once daily, while for those weighing over 80kg, enoxaparin sodium 4000IU was administered every 12 hours. After discharge, these patients were switched to oral low-dose warfarin for anticoagulation, with a daily dose of 1.25mg (half tablet) on dialysis days, and 2.5mg/day on non-dialysis days. Patients with significantly excessive body weight may be considered for a daily dose of 2.5mg, with a total treatment duration of 4 weeks.
Intervention: Low molecular weight heparin (Drug)
control group
Patients in the control group did not receive anticoagulants postoperatively, but both groups routinely received antiplatelet therapy.
Intervention: non anticoagulant therapy group (Other)
Outcomes
Primary Outcomes
Blood flow of arteriovenous fistula
Time Frame: up to 12 months
Blood flow of arteriovenous fistula during hemodialysis from 6 months after operation
arteriovenous fistula dysfunction or occlusion
Time Frame: up to 12 months
The time of arteriovenous fistula dysfunction or occlusion
Active bleeding events
Time Frame: up to 12 months
such as,bleeding of surgical wound, intracranial, digestive tract and urinary tract, ecchymosis and ecchymosis of skin.
AVF Maturation Failure AVF Maturation Failure AVF Maturation Failure AVF Maturation Failure AVF maturation failure
Time Frame: up to 2 months
AVF maturation failure two months postoperatively
Secondary Outcomes
- coagulation index(up to 12 months)
- Platelet(up to 12 months)
- Number of hospitalization(up to 12 months)
- Death(up to 12 months)
Investigators
Yunfeng Xia
Clinical Professor
First Affiliated Hospital of Chongqing Medical University