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

NCT ID: NCT04164693

Last Updated: 2024-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 287 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2022-09-30

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.

Conditions

Thrombosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Low molecular weight heparin

Intervention Type: DRUG

patients began to use low molecular weight heparin or warfarin sodium tablets.

control group

Patients in the control group did not receive anticoagulants postoperatively, but both groups routinely received antiplatelet therapy.

Group Type: OTHER

non anticoagulant therapy group

Intervention Type: OTHER

no anticoagulant was used after operation.

Interventions

Low molecular weight heparin

patients began to use low molecular weight heparin or warfarin sodium tablets.

Intervention Type: DRUG

non anticoagulant therapy group

no anticoagulant was used after operation.

Intervention Type: OTHER

Other Intervention Names

warfarin sodium tablets

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yunfeng Xia

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hua Gan, Dr.

Role: STUDY_DIRECTOR

First Affiliated Hospital of Chongqing Medical University

Locations

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Countries

China

Other Identifiers

The First ChongQingMU

Identifier Type: -

Identifier Source: org_study_id