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

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 Overview

• Status: Completed
• Conditions: Thrombosis
• Intervention / Treatment: Drug: Low molecular weight heparin; Other: non anticoagulant therapy group

• Study Type: Interventional
• Enrollment (Actual): 287
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400016
      • The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Low molecular weight heparin; patients began to use low molecular weight heparin or warfarin sodium tablets.; Other Names: warfarin sodium tablets
Other: control group; Patients in the control group did not receive anticoagulants postoperatively, but both groups routinely received antiplatelet therapy.	Other: non anticoagulant therapy group; no anticoagulant was used after operation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood flow of arteriovenous fistula	Blood flow of arteriovenous fistula during hemodialysis from 6 months after operation	up to 12 months
arteriovenous fistula dysfunction or occlusion	The proportion of arteriovenous fistula dysfunction or occlusion	up to 12 months
Active bleeding events	such as,bleeding of surgical wound, intracranial, digestive tract and urinary tract, ecchymosis and ecchymosis of skin.	up to 12 months
arteriovenous fistula dysfunction or occlusion	The time of arteriovenous fistula dysfunction or occlusion	up to 12 months
AVF Maturation Failure AVF Maturation Failure AVF Maturation Failure AVF Maturation Failure AVF maturation failure	AVF maturation failure two months postoperatively	up to 2 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Chongqing Medical University
• Investigators: Study Director: Hua Gan, Dr., First Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: November 9, 2019
• First Submitted That Met QC Criteria: November 13, 2019
• First Posted (Actual): November 15, 2019

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: June 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: arteriovenous fistula; bleeding risk; anticoagulant therapy; manitenance hemodialysis; fistula function
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Pathological Conditions, Anatomical; Fistula; Thrombosis; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin; Warfarin
• Other Study ID Numbers: The First ChongQingMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No