Clinical trial NCT03804697: Selective Thromboembolism Prophylaxis After Arthroplasty
Official title: Selective Thromboembolism Prophylaxis After Total Hip Arthroplasty or Total Knee Arthroplasty by a Risk Stratification With Thromboelastography for Asian Populations: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Thrombosis, Deep
Arthroplasty Complications
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 197
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Incidence of Deep Vein Thrombosis
timeFrame: 1 day after surgery
measure: The Incidence of Deep Vein Thrombosis
timeFrame: 3 days after surgery
measure: The Incidence of Deep Vein Thrombosis
timeFrame: 5 days after surgery
measure: The Incidence of Deep Vein Thrombosis
timeFrame: 1 month after surgery
measure: The Incidence of Deep Vein Thrombosis
timeFrame: 3 months after surgery
measure: The Incidence of Deep Vein Thrombosis
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Hematocrit
timeFrame: 1 day before surgery
measure: Hematocrit
timeFrame: 1 day after surgery
measure: Hematocrit
timeFrame: 3 days after surgery
measure: Hematocrit
timeFrame: 5 days after surgery
measure: Hemoglobin
timeFrame: 1 day before surgery
measure: Hemoglobin
timeFrame: 1 day after surgery
measure: Hemoglobin
timeFrame: 3 days after surgery
measure: Hemoglobin
timeFrame: 5 days after surgery
measure: Red Blood Cell
timeFrame: 1 day before surgery
measure: Red Blood Cell
timeFrame: 1 day after surgery
measure: Red Blood Cell
timeFrame: 3 days after surgery
measure: Red Blood Cell
timeFrame: 5 days after surgery
measure: Volume of Transfusion
timeFrame: During Hospitalization
measure: Transfusion Rate
timeFrame: During Hospitalization
measure: Superficial Infection
timeFrame: During Hospitalization
measure: Superficial Infection
timeFrame: 1 month after surgery
measure: Superficial Infection
timeFrame: 3 months after surgery
measure: Superficial Infection
timeFrame: 6 months after surgery
measure: Deep Infection
timeFrame: During Hospitalization
measure: Deep Infection
timeFrame: 1 month after surgery
measure: Deep Infection
timeFrame: 3 months after surgery
measure: Deep Infection
timeFrame: 6 months after surgery
measure: Ecchymosis incidence Rate
timeFrame: 1 month after surgery
Other outcomes:
Locations:
Study officials:
References: