Selective Thromboembolism Prophylaxis After Arthroplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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Selective Thromboembolism Prophylaxis After Total Hip Arthroplasty or Total Knee Arthroplasty by a Risk Stratification With Thromboelastography for Asian Populations: A Randomized Control Trial

Conditions
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Venous Thrombosis, Deep, Arthroplasty Complications

Intervention / Treatment
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* Drug: selective anticoagulation


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: selective anticoagulation group<br>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. | Drug: selective anticoagulation<br>* Selective anticoagulation group used anticoagulant once thromboelastography indicated hypercoagulable state. Conventional anticoagulation group used anticoagulant until one month after surgery routinely. The main difference was that the experimental group did not use anticoagulation if the thromboelastography indicated that the blood coagulation status was normal while the control group use anticoagulation routinely.<br>* Other names: Thromboelastography;|
| Active Comparator: conventional anticoagulation group<br>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. | Drug: selective anticoagulation<br>* Selective anticoagulation group used anticoagulant once thromboelastography indicated hypercoagulable state. Conventional anticoagulation group used anticoagulant until one month after surgery routinely. The main difference was that the experimental group did not use anticoagulation if the thromboelastography indicated that the blood coagulation status was normal while the control group use anticoagulation routinely.<br>* Other names: Thromboelastography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Incidence of Deep Vein Thrombosis | Measured by ultrasound, | 1 day after surgery | 
| The Incidence of Deep Vein Thrombosis | Measured by ultrasound | 3 days after surgery | 
| The Incidence of Deep Vein Thrombosis | Measured by ultrasound | 5 days after surgery | 
| The Incidence of Deep Vein Thrombosis | Measured by ultrasound | 1 month after surgery | 
| The Incidence of Deep Vein Thrombosis | Measured by ultrasound | 3 months after surgery | 
| The Incidence of Deep Vein Thrombosis | Measured by ultrasound | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematocrit | Measured by Complete Blood Count | 1 day before surgery | 
| Hematocrit | Measured by Complete Blood Count | 1 day after surgery | 
| Hematocrit | Measured by Complete Blood Count | 3 days after surgery | 
| Hematocrit | Measured by Complete Blood Count | 5 days after surgery | 
| Hemoglobin | Number of Hemoglobin Measured by Blood Test | 1 day before surgery | 
| Hemoglobin | Number of Hemoglobin Measured by Blood Test | 1 day after surgery | 
| Hemoglobin | Number of Hemoglobin Measured by Blood Test | 3 days after surgery | 
| Hemoglobin | Number of Hemoglobin Measured by Blood Test | 5 days after surgery | 
| Red Blood Cell | Number of Red Blood Cell Measured by Complete Blood Count | 1 day before surgery | 
| Red Blood Cell | Number of Red Blood Cell Measured by Complete Blood Count | 1 day after surgery | 
| Red Blood Cell | Number of Red Blood Cell Measured by Complete Blood Count | 3 days after surgery | 
| Red Blood Cell | Number of Red Blood Cell Measured by Complete Blood Count | 5 days after surgery | 
| Volume of Transfusion | Volume of Blood Transfusion | During Hospitalization | 
| Transfusion Rate | Number of patients who receive transfusion divided by total number of patients in the group | During Hospitalization | 
| Superficial Infection | Number of patients who suffer superficial infection | During Hospitalization | 
| Superficial Infection | Number of patients who suffer superficial infection | 1 month after surgery | 
| Superficial Infection | Number of patients who suffer superficial infection | 3 months after surgery | 
| Superficial Infection | Number of patients who suffer superficial infection | 6 months after surgery | 
| Deep Infection | Number of patients who suffer deep infection | During Hospitalization | 
| Deep Infection | Number of patients who suffer deep infection | 1 month after surgery | 
| Deep Infection | Number of patients who suffer deep infection | 3 months after surgery | 
| Deep Infection | Number of patients who suffer deep infection | 6 months after surgery | 
| Ecchymosis incidence Rate | Number of patients who suffer ecchymosis divided by total number of patients in the group | 1 month after surgery |