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CompletedNCT04164693EASOATUpdated Jun 24, 2024

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

An interventional study of Low molecular weight heparin and non anticoagulant therapy group in Thrombosis, sponsored by First Affiliated Hospital of Chongqing Medical University. Completed at 1 site in China. Open to participants aged 20 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-24.

Sponsored by First Affiliated Hospital of Chongqing Medical University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jan 2019, registered Nov 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
287
Allocation
Randomized
Ages
20 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Thrombosis

Keywords

  • manitenance hemodialysis
  • arteriovenous fistula
  • anticoagulant therapy
  • fistula function
  • bleeding risk
03

In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's enrollment of 287 is above the median of 106 across 849 interventional studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

First Affiliated Hospital of Chongqing Medical University is the lead sponsor of 95 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
287 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugLow molecular weight heparin

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

    Also known as: warfarin sodium tablets

  • Othernon anticoagulant therapy group

    no anticoagulant was used after operation.

06

What researchers measure

Primary outcomes

  1. Blood flow of arteriovenous fistula

    Blood flow of arteriovenous fistula during hemodialysis from 6 months after operation

    Time frame: up to 12 months

  2. arteriovenous fistula dysfunction or occlusion

    The proportion of arteriovenous fistula dysfunction or occlusion

    Time frame: up to 12 months

  3. Active bleeding events

    such as,bleeding of surgical wound, intracranial, digestive tract and urinary tract, ecchymosis and ecchymosis of skin.

    Time frame: up to 12 months

  4. arteriovenous fistula dysfunction or occlusion

    The time of arteriovenous fistula dysfunction or occlusion

    Time frame: up to 12 months

  5. AVF Maturation Failure AVF Maturation Failure AVF Maturation Failure AVF Maturation Failure AVF maturation failure

    AVF maturation failure two months postoperatively

    Time frame: up to 2 months

Secondary outcomes

  1. coagulation index

    Change of coagulation index

    Time frame: up to 12 months

  2. Platelet

    Changes of platelet indexes

    Time frame: up to 12 months

  3. Number of hospitalization

    Number of hospitalization due to arteriovenous fistula thrombosis.

    Time frame: up to 12 months

  4. Death

    Death from any cause

    Time frame: up to 12 months

07

Study locations

1 site
  • The First Affiliated Hospital of Chongqing Medical University
    Chongqing, Chongqing 400016, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04164693
Lead sponsor
First Affiliated Hospital of Chongqing Medical University
Responsible party
Yunfeng Xia (Clinical Professor, First Affiliated Hospital of Chongqing Medical University) — Principal investigator
First posted
Nov 15, 2019
Start date
Jan 1, 2019
Primary completion
Sep 1, 2022
Completion
Sep 30, 2022
Last update
Jun 24, 2024

Study contacts

Hua Gan, Dr.
study director · First Affiliated Hospital of Chongqing Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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