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

June 21, 2024 updated by: Yunfeng Xia, First Affiliated Hospital of Chongqing Medical University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
287

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Yunfeng Xia, Dr.
  • Phone Number: 86-23-89012256
  • Email: xyf0920@126.com

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blood flow of arteriovenous fistula
Time Frame: up to 12 months
Blood flow of arteriovenous fistula during hemodialysis from 6 months after operation
up to 12 months
arteriovenous fistula dysfunction or occlusion
Time Frame: up to 12 months
The proportion of arteriovenous fistula dysfunction or occlusion
up to 12 months
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.
up to 12 months
arteriovenous fistula dysfunction or occlusion
Time Frame: up to 12 months
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
Time Frame: up to 2 months
AVF maturation failure two months postoperatively
up to 2 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
coagulation index
Time Frame: up to 12 months
Change of coagulation index
up to 12 months
Platelet
Time Frame: up to 12 months
Changes of platelet indexes
up to 12 months
Number of hospitalization
Time Frame: up to 12 months
Number of hospitalization due to arteriovenous fistula thrombosis.
up to 12 months
Death
Time Frame: up to 12 months
Death from any cause
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital of Chongqing Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Hua Gan, Dr., First Affiliated Hospital of Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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