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

NCT04164693 | Completed

• 1 other identifier: The First ChongQingMU
• Study Type: interventional
• Target: 287
• Locations: 1 country
• Sites: 1

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

Keywords

manitenance hemodialysis; arteriovenous fistula; anticoagulant therapy; fistula function; bleeding risk

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• coagulation index

  up to 12 months

• Platelet

  up to 12 months

• Number of hospitalization

  up to 12 months

• Death

  up to 12 months

Study Arms (2)

anticoagulant group

EXPERIMENTAL

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

control group

OTHER

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

Other: non anticoagulant therapy group

Interventions

Low molecular weight heparin DRUG

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

Also known as: warfarin sodium tablets

anticoagulant group

non anticoagulant therapy group OTHER

no anticoagulant was used after operation.

control group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

MeSH Terms

Conditions

Thrombosis; Arteriovenous Fistula

Interventions

Heparin, Low-Molecular-Weight; Warfarin

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Vascular Fistula; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hua Gan, Dr.

  First Affiliated Hospital of Chongqing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: The enrolled patients will be randomly assigned to either the anticoagulant group or the control group. Patients in the anticoagulant group will receive a low-dose subcutaneous injection of low molecular weight heparin for the prevention of AVF thrombosis, starting 12-24 hours after the surgery. For patients weighing less than 80kg, enoxaparin sodium 4000IU will be administered once daily, while for those weighing over 80kg, enoxaparin sodium 4000IU will be administered every 12 hours. After discharge, these patients will be 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. Patients in the control group will not receive anticoagulants postoperatively, but both groups will routinely receive antiplatelet therapy.

Study Record Dates

• First Submitted: November 9, 2019
• First Posted: November 15, 2019
• Study Start: January 1, 2019
• Primary Completion: September 1, 2022
• Study Completion: September 30, 2022
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)