Venous Thromboembolism, Arthroplasty
Conditions
Brief summary
Venous thromboembolism is a serious complication after total hip replacement (THR) and total knee replacement (TKR). Previous studies have reported the incidence of both asymptomatic and symptomatic deep vein thrombosis (DVT) after TKR were higher in Taiwan than other countries in Asia. Therefore, the usage of prophylactic antithrombotics should be considered. The efficacy and safety of Xarelto (Rivaroxaban) for preventing venous thromboembolism has been proved. However, there is a lack of study using prospective design to evaluate the efficacy and safety of Xarelto after THR and TKR for Taiwanese. In this study, the investigators use a randomized controlled trial design comparing the incidence of DVT, pulmonary embolism, and complications between intervention and control groups.
Detailed description
This parallel study is conducted in a single hospital. The participants are divided into two groups. One group is provided with Xarelto, and the other one group is provided without any prophylactic antithrombotic. To check the presence of a deep vein thrombosis of the lower limb, bilateral sonographic examinations are arranged for all participants preoperatively and at 3 and 14 days postoperatively. One radiologists who was blinded to the nature of the study interpreted the results of the sonographic examination. The present of pulmonary embolism, DVT-related symptoms, and complications are recorded during the 3-months follow-up in orthopedics outpatients. The symptom which associated with DVT is defined as the signs of leg such as unusual pain, edema, swelling, warm skin, and red or discolored skin. Complications related to Xarelto include major bleeding, infection, and non-healing wound. The expected number of participants in each group is 89, which is calculated by G \* Power version 3.1. The intention to treat analysis is used in this study. The investigators compare the incidences of DVT, pulmonary embolism, and complications between the two groups.
Interventions
Patients are randomly divided into two groups. One group receives no prophylaxis with an anticoagulant, the other one receives Rivaroxaban. The dosage of Rivaroxaban is 10 mg given orally once daily starting on the day of the surgery and continuing the following 13 days.
Sponsors
Chiayi Christian Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergo total knee replacement or total hip replacement
Exclusion criteria
* Recent antithrombotics use * A history of a coagulopathy * Recent thromboembolic disease * Preoperative deep vein thrombosis screening presents positive * Age below 20
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Deep vein thrombosis | Up to 3 months after THR and TKR | The incidence of both asymptomatic and symptomatic deep vein thrombosis |
| Pulmonary embolism | Up to 3 months after THR and TKR | The incidence of pulmonary embolism |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication | Up to 3 months after THR and TKR | Major bleeding, infection, and non-healing wound |
Countries
Taiwan
Contacts
Primary ContactCheng-Ming Chou
Outcome results
None listed