Selective Thromboembolism Prophylaxis After Arthroplasty

NCT ID: NCT03804697

Last Updated: 2019-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-01
• Study Completion Date: 2018-01-01

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.

Conditions

Venous Thrombosis, Deep; Arthroplasty Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

selective anticoagulation group

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.

Group Type: EXPERIMENTAL

selective anticoagulation

Intervention Type: DRUG

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.

conventional anticoagulation group

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.

Group Type: ACTIVE_COMPARATOR

selective anticoagulation

Intervention Type: DRUG

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.

Interventions

selective 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.

Intervention Type: DRUG

Other Intervention Names

Thromboelastography

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2016-46

Identifier Type: -

Identifier Source: org_study_id