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

Primary Purpose

Thrombosis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Low molecular weight heparin
non anticoagulant therapy group
Sponsored by
First Affiliated Hospital of Chongqing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thrombosis focused on measuring manitenance hemodialysis patients, arteriovenous fistula operation, Thrombosis, anticoagulant therapy, Efficacy, safety

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • the participants were treated with autogenous arteriovenous fistula, reconstruction and balloon dilatation;
  • stable health, compliant with treatment, and active following treatment. Exclusion Criteria.
  • age > 85 years old;
  • history of blood system diseases;
  • history of familial and hereditary bleeding diseases;
  • important complications affecting the coagulation system, such as liver diseases;
  • abnormal coagulation function and active bleeding;
  • history of intracranial and digestive tract bleeding, obvious skin stasis;
  • complications, such as surgery and tumor, which significantly increase the risk of bleeding;
  • no subjective will.

Sites / Locations

  • The First Affiliated Hospital of Chongqing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

anticoagulant therapy group

non anticoagulant therapy group

Arm Description

during hospitalization, patients began to use low molecular weight heparin subcutaneously after arteriovenous fistula operation, once or twice a day, 4000iu-8000iu a day. After discharge, the patients took warfarin sodium tablets orally, 1.25mg on dialysis day, 2.5mg on non dialysis day, for a total course of 4 weeks.

no anticoagulant was used after operation, but both groups could take antiplatelet drugs.

Outcomes

Primary Outcome Measures

Blood flow of arteriovenous fistula
Blood flow of arteriovenous fistula during hemodialysis from 6 months after operation
arteriovenous fistula dysfunction or occlusion
The proportion of arteriovenous fistula dysfunction or occlusion
Active bleeding events
such as,bleeding of surgical wound, intracranial, digestive tract and urinary tract, ecchymosis and ecchymosis of skin.
arteriovenous fistula dysfunction or occlusion
The time of arteriovenous fistula dysfunction or occlusion

Secondary Outcome Measures

coagulation index
Change of coagulation index
Platelet
Changes of platelet indexes
Number of hospitalization
Number of hospitalization due to arteriovenous fistula thrombosis.

Full Information

First Posted
November 9, 2019
Last Updated
November 13, 2019
Sponsor
First Affiliated Hospital of Chongqing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04164693
Brief Title
Efficacy and Safety of Short-term Postoperative Anticoagulant Therapy to Prevente Thrombosis in Arterovenous Fistula
Acronym
EASOAT
Official Title
Efficacy and Safety of Short-term Postoperative Anticoagulant Therapy to Prevente Thrombosis in Arterovenous Fistula
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
October 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Chongqing Medical University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis
Keywords
manitenance hemodialysis patients, arteriovenous fistula operation, Thrombosis, anticoagulant therapy, Efficacy, safety

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
we plan to recruite the patients with arteriovenous fistula in the blood purification center of our hospital. After recruitment, the patients were randomly assigned to anticoagulant therapy group or non anticoagulant therapy group. anticoagulant therapy group: during hospitalization, patients began to use low molecular weight heparin subcutaneously after arteriovenous fistula operation, once or twice a day, 4000iu-8000iu a day. After discharge, the patients took warfarin sodium tablets orally, 1.25mg on dialysis day, 2.5mg on non dialysis day, for a total course of 4 weeks. non anticoagulant therapy group: no anticoagulant was used after operation, but both groups could take antiplatelet drugs.Efficacy and safety of short-term postoperative anticoagulant therapy to prevente thrombosis were evaluated.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
anticoagulant therapy group
Arm Type
Experimental
Arm Description
during hospitalization, patients began to use low molecular weight heparin subcutaneously after arteriovenous fistula operation, once or twice a day, 4000iu-8000iu a day. After discharge, the patients took warfarin sodium tablets orally, 1.25mg on dialysis day, 2.5mg on non dialysis day, for a total course of 4 weeks.
Arm Title
non anticoagulant therapy group
Arm Type
Other
Arm Description
no anticoagulant was used after operation, but both groups could take antiplatelet drugs.
Intervention Type
Drug
Intervention Name(s)
Low molecular weight heparin
Other Intervention Name(s)
warfarin sodium tablets
Intervention Description
patients began to use low molecular weight heparin or warfarin sodium tablets.
Intervention Type
Other
Intervention Name(s)
non anticoagulant therapy group
Intervention Description
no anticoagulant was used after operation.
Primary Outcome Measure Information:
Title
Blood flow of arteriovenous fistula
Description
Blood flow of arteriovenous fistula during hemodialysis from 6 months after operation
Time Frame
up to 6 months
Title
arteriovenous fistula dysfunction or occlusion
Description
The proportion of arteriovenous fistula dysfunction or occlusion
Time Frame
up to 6 months
Title
Active bleeding events
Description
such as,bleeding of surgical wound, intracranial, digestive tract and urinary tract, ecchymosis and ecchymosis of skin.
Time Frame
up to 6 months
Title
arteriovenous fistula dysfunction or occlusion
Description
The time of arteriovenous fistula dysfunction or occlusion
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
coagulation index
Description
Change of coagulation index
Time Frame
up to 6 months
Title
Platelet
Description
Changes of platelet indexes
Time Frame
up to 6 months
Title
Number of hospitalization
Description
Number of hospitalization due to arteriovenous fistula thrombosis.
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: the participants were treated with autogenous arteriovenous fistula, reconstruction and balloon dilatation; stable health, compliant with treatment, and active following treatment. Exclusion Criteria. age > 85 years old; history of blood system diseases; history of familial and hereditary bleeding diseases; important complications affecting the coagulation system, such as liver diseases; abnormal coagulation function and active bleeding; history of intracranial and digestive tract bleeding, obvious skin stasis; complications, such as surgery and tumor, which significantly increase the risk of bleeding; no subjective will.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yunfeng Xia, Dr.
Phone
86-23-89012256
Email
xyf0920@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hua Gan, Dr.
Organizational Affiliation
First Affiliated Hospital of Chongqing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunfeng Xia, Dr.
Phone
86-23-89012256
Email
xyf0920@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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