Clinical trial NCT04164693: Efficacy and Safety of Short-term Postoperative Anticoagulant Therapy to Prevente Thrombosis in Arterovenous Fistula
Official title: Efficacy and Safety of Short-term Postoperative Anticoagulant Therapy to Prevente Thrombosis in Arterovenous Fistula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thrombosis
Keywords: manitenance hemodialysis
arteriovenous fistula
anticoagulant therapy
fistula function
bleeding risk
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 287
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The enrolled patients will be randomly assigned to either the anticoagulant group or the control group. Patients in the anticoagulant group will receive a low-dose subcutaneous injection of low molecular weight heparin for the prevention of AVF thrombosis, starting 12-24 hours after the surgery. For patients weighing less than 80kg, enoxaparin sodium 4000IU will be administered once daily, while for those weighing over 80kg, enoxaparin sodium 4000IU will be administered every 12 hours. After discharge, these patients will be 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. Patients in the control group will not receive anticoagulants postoperatively, but both groups will routinely receive antiplatelet therapy.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Blood flow of arteriovenous fistula
timeFrame: up to 12 months
measure: arteriovenous fistula dysfunction or occlusion
timeFrame: up to 12 months
measure: Active bleeding events
timeFrame: up to 12 months
measure: arteriovenous fistula dysfunction or occlusion
timeFrame: up to 12 months
measure: AVF Maturation Failure AVF Maturation Failure AVF Maturation Failure AVF Maturation Failure AVF maturation failure
timeFrame: up to 2 months
Secondary outcomes:
measure: coagulation index
timeFrame: up to 12 months
measure: Platelet
timeFrame: up to 12 months
measure: Number of hospitalization
timeFrame: up to 12 months
measure: Death
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Hua Gan, Dr.
role: STUDY_DIRECTOR
References: