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

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

Sponsors

Lead Sponsor: First Affiliated Hospital of Chongqing Medical University

Source First Affiliated Hospital of Chongqing Medical University
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.

Overall Status Recruiting
Start Date January 1, 2019
Completion Date October 1, 2020
Primary Completion Date June 1, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Blood flow of arteriovenous fistula up to 6 months
arteriovenous fistula dysfunction or occlusion up to 6 months
Active bleeding events up to 6 months
arteriovenous fistula dysfunction or occlusion up to 6 months
Secondary Outcome
Measure Time Frame
coagulation index up to 6 months
Platelet up to 6 months
Number of hospitalization up to 6 months
Enrollment 110
Condition
Intervention

Intervention Type: Drug

Intervention Name: Low molecular weight heparin

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

Arm Group Label: anticoagulant therapy group

Other Name: warfarin sodium tablets

Intervention Type: Other

Intervention Name: non anticoagulant therapy group

Description: no anticoagulant was used after operation.

Arm Group Label: non anticoagulant therapy group

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.

Gender: All

Minimum Age: 20 Years

Maximum Age: 85 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Hua Gan, Dr. Study Director First Affiliated Hospital of Chongqing Medical University
Overall Contact

Last Name: Yunfeng Xia, Dr.

Phone: 86-23-89012256

Email: [email protected]

Location
Facility: Status: Contact: The First Affiliated Hospital of Chongqing Medical University Yunfeng Xia, Dr. 86-23-89012256 [email protected]
Location Countries

China

Verification Date

November 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: First Affiliated Hospital of Chongqing Medical University

Investigator Full Name: Yunfeng Xia

Investigator Title: Clinical Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: anticoagulant therapy group

Type: Experimental

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.

Label: non anticoagulant therapy group

Type: Other

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

Acronym EASOAT
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention 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.

Primary Purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov