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

Thrombosis Clinical Trial

— EASOAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04164693
• Other study ID #: The First ChongQingMU
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: November 2019
• Source: First Affiliated Hospital of Chongqing Medical University
• Contact: Yunfeng Xia, Dr.
• Phone: 86-23-89012256
• Email: xyf0920[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: October 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fistula
• Thrombosis

Intervention

Drug:
• Low molecular weight heparin
patients began to use low molecular weight heparin or warfarin sodium tablets.

Other:
• non anticoagulant therapy group
no anticoagulant was used after operation.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood flow of arteriovenous fistula	Blood flow of arteriovenous fistula during hemodialysis from 6 months after operation	up to 6 months
Primary	arteriovenous fistula dysfunction or occlusion	The proportion of arteriovenous fistula dysfunction or occlusion	up to 6 months
Primary	Active bleeding events	such as,bleeding of surgical wound, intracranial, digestive tract and urinary tract, ecchymosis and ecchymosis of skin.	up to 6 months
Primary	arteriovenous fistula dysfunction or occlusion	The time of arteriovenous fistula dysfunction or occlusion	up to 6 months
Secondary	coagulation index	Change of coagulation index	up to 6 months
Secondary	Platelet	Changes of platelet indexes	up to 6 months
Secondary	Number of hospitalization	Number of hospitalization due to arteriovenous fistula thrombosis.	up to 6 months