Selective Thromboembolism Prophylaxis After Arthroplasty
- Conditions
- Venous Thrombosis, DeepArthroplasty Complications
- Interventions
- Drug: selective anticoagulation
- Registration Number
- NCT03804697
- Lead Sponsor
- Guangdong Provincial People's Hospital
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 197
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description selective anticoagulation group selective anticoagulation 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. conventional anticoagulation group selective anticoagulation 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.
- Primary Outcome Measures
Name Time Method The Incidence of Deep Vein Thrombosis 6 months after surgery Measured by ultrasound
- Secondary Outcome Measures
Name Time Method Hematocrit 5 days after surgery Measured by Complete Blood Count
Hemoglobin 5 days after surgery Number of Hemoglobin Measured by Blood Test
Red Blood Cell 5 days after surgery Number of Red Blood Cell Measured by Complete Blood Count
Volume of Transfusion During Hospitalization Volume of Blood Transfusion
Transfusion Rate During Hospitalization Number of patients who receive transfusion divided by total number of patients in the group
Ecchymosis incidence Rate 1 month after surgery Number of patients who suffer ecchymosis divided by total number of patients in the group
Superficial Infection 6 months after surgery Number of patients who suffer superficial infection
Deep Infection 6 months after surgery Number of patients who suffer deep infection