Arthroplasty Complications, Venous Thrombosis, Deep
Conditions
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.
Interventions
DRUGselective anticoagulation
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.
Sponsors
Guangdong Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Incidence of Deep Vein Thrombosis | 1 day after surgery | Measured by ultrasound, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin | 1 day before surgery | Number of Hemoglobin Measured by Blood Test |
| Red Blood Cell | 1 day before surgery | Number of Red Blood Cell Measured by Complete Blood Count |
| Volume of Transfusion | During Hospitalization | Volume of Blood Transfusion |
| Hematocrit | 1 day before surgery | Measured by Complete Blood Count |
| Superficial Infection | During Hospitalization | Number of patients who suffer superficial infection |
| Deep Infection | During Hospitalization | Number of patients who suffer deep infection |
| Ecchymosis incidence Rate | 1 month after surgery | Number of patients who suffer ecchymosis divided by total number of patients in the group |
| Transfusion Rate | During Hospitalization | Number of patients who receive transfusion divided by total number of patients in the group |
Outcome results
None listed