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NCT Number: NCT04164693

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

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.

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Key information

Conditions

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

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low molecular weight heparin

Drug

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

Other names: warfarin sodium tablets

non anticoagulant therapy group

Other

no anticoagulant was used after operation.

Primary outcomes

  1. Blood flow of arteriovenous fistula

    Time frame: up to 12 months

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

  2. arteriovenous fistula dysfunction or occlusion

    Time frame: up to 12 months

    The proportion of arteriovenous fistula dysfunction or occlusion

  3. Active bleeding events

    Time frame: up to 12 months

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

  4. arteriovenous fistula dysfunction or occlusion

    Time frame: up to 12 months

    The time of arteriovenous fistula dysfunction or occlusion

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

    Time frame: up to 2 months

    AVF maturation failure two months postoperatively

Secondary outcomes

  1. coagulation index

    Time frame: up to 12 months

    Change of coagulation index

  2. Platelet

    Time frame: up to 12 months

    Changes of platelet indexes

  3. Number of hospitalization

    Time frame: up to 12 months

    Number of hospitalization due to arteriovenous fistula thrombosis.

  4. Death

    Time frame: up to 12 months

    Death from any cause

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Other

Registry information

Acronym: EASOAT

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 15, 2019
Registry last updated
Jun 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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