Selective Thromboembolism Prophylaxis After Arthroplasty

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status: Completed

Conditions: Venous Thrombosis, Deep; Arthroplasty Complications

Treatments: Drug: selective anticoagulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03804697

2016-46 (Other Identifier)

Details and patient eligibility

About

Asian populations have a lower rate of high-risk gene mutations of venous thrombosis, which means a reasonable perioperative anticoagulant management after hip or knee arthroplasty for Caucasian populations may be too excessive for Asians. So, individual patient risk assessment, rather than a "blanket policy", is considered the best thromboembolism prophylaxis for Asians.The purpose of this study was to evaluate the effectiveness and safety of selective thromboembolism prophylaxis compared with conventional thromboembolism prophylaxis by risk stratification with thromboelastography (TEG) after joint arthroplasty for Asian populations.

Full description

Asian patients who underwent hip or knee arthroplasty in Guangdong General Hospital from August 2016 to August 2017 were randomly divided into selective anticoagulation group (SAG) and conventional anticoagulation group (CAG). SAG used anticoagulant when TEG indicated hypercoagulability while CAP used anticoagulant until one month after surgery regularly. Data including patients' basic information, postoperative complications, perioperative clotting index, intraoperative blood loss, perioperative TEG, volume of drainage, and blood transfusion were evaluated.

Enrollment: 197 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• over 18 years of age,
• ASA Ⅰ-Ⅱ grade,
• BMI <40Kg / M ^ 2
• Underwent total knee arthroplasty/ total hip arthroplasty in Guangdong General Hospital
• consent to enroll in this study

Exclusion criteria

• history of VTE, preoperative infection, preoperative coagulation
• liver and kidney function existed clinically abnormalities
• history of tumor
• history of vascular surgery
• heart infarction or cerebral infarction within 6 months
• history of lower extremity surgery within 3 months

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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197 participants in 2 patient groups

selective anticoagulation group

Experimental group

Description:

Selective anticoagulation group used anticoagulant when thromboelastogram（TEG） indicated hypercoagulability. TEG was performed 1 day before the surgery, 1 day after the surgery, 3 days after the surgery, and 5 days after the surgery. The dosage regimen of anticoagulant was hypodermic injection 0.4 ml low molecular weight heparin per day for 5 days and oral administration of 10 mg Rivaroxaban until one month after the surgery.

Treatment:

Drug: selective anticoagulation

conventional anticoagulation group

Active Comparator group

Description:

The Intervention for conventional anticoagulation group was using anticoagulant until one month after surgery routinely. The dosage regimen of anticoagulant was hypodermic injection 0.4 ml low molecular weight heparin per day for 5 days and oral administration of 10 mg Rivaroxaban until one month after the surgery.

Treatment:

Drug: selective anticoagulation