Efficacy and Safety of Short-term Postoperative Anticoagulant Therapy to Prevente Thrombosis in Arterovenous Fistula

Not Applicable

Completed

• Conditions: Thrombosis
• Interventions: Other: non anticoagulant therapy group; Drug: Low molecular weight heparin

• Registration Number: NCT04164693
• Lead Sponsor: First Affiliated Hospital of Chongqing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-11-09
• Study First Submitted QC: 2019-11-13
• Study First Posted: 2019-11-15
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 287

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	non anticoagulant therapy group	Patients in the control group did not receive anticoagulants postoperatively, but both groups routinely received antiplatelet therapy.
anticoagulant group	Low molecular weight heparin	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.

Primary Outcome Measures

Name	Time	Method
Blood flow of arteriovenous fistula	up to 12 months	Blood flow of arteriovenous fistula during hemodialysis from 6 months after operation
arteriovenous fistula dysfunction or occlusion	up to 12 months	The time of arteriovenous fistula dysfunction or occlusion
Active bleeding events	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	up to 2 months	AVF maturation failure two months postoperatively

Secondary Outcome Measures

Name	Time	Method
coagulation index	up to 12 months	Change of coagulation index
Platelet	up to 12 months	Changes of platelet indexes
Number of hospitalization	up to 12 months	Number of hospitalization due to arteriovenous fistula thrombosis.
Death	up to 12 months	Death from any cause

Trial Locations

Locations (1)

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China