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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban | Experimental | The participants are provided with Rivaroxaban 10mg |
|
| Control | No Intervention | The participants are provided without antithrombotics |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban 10 MG | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Deep Vein Thrombosis | The incidence of both asymptomatic and symptomatic deep vein thrombosis | Up to 3 months after THR and TKR |
| Pulmonary Embolism | The incidence of pulmonary embolism | Up to 3 months after THR and TKR |
| Measure | Description | Time Frame |
|---|---|---|
| Complication | Major bleeding, infection, and non-healing wound | Up to 3 months after THR and TKR |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ditmanson Medical Foundation Chiayi Christian Hospital | Chiayi City | Taiwan | 60002 | Taiwan |
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A total of 158 patients were assessed for eligibility. Eight patients were excluded due to not meeting inclusion or exclusion criteria. A total of 150 patients were enrolled and assigned to the rivaroxaban or control groups.
Participants were prospectively enrolled at a single tertiary medical center between February 2023 and December 2025. Patients undergoing total hip or total knee arthroplasty were screened for eligibility.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rivaroxaban | The participants are provided with Rivaroxaban 10mg |
| FG001 | Control | The participants are provided without antithrombotics |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants were included in the baseline analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rivaroxaban | The participants are provided with Rivaroxaban 10mg |
| BG001 | Control | The participants are provided without antithrombotics |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The analysis population included all randomized participants. No participants were excluded from the analysis. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Deep Vein Thrombosis | The incidence of both asymptomatic and symptomatic deep vein thrombosis | Posted | Count of Participants | Participants | Up to 3 months after THR and TKR |
|
|
From the day of surgery until 3 months postoperatively.
Adverse events were assessed prospectively from the day of surgery until 3 months postoperatively. Deep vein thrombosis was detected by routine duplex ultrasonography on postoperative day 3 and day 14, and symptomatic venous thromboembolism was evaluated clinically during follow-up visits. Major bleeding events were defined as gastrointestinal or intracranial hemorrhage requiring medical intervention. All randomized participants were included in the adverse event analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rivaroxaban | The participants are provided with Rivaroxaban 10mg | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep vein thrombosis | Vascular disorders | Systematic Assessment | Diagnosed by routine duplex ultrasonography |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cheng-Ming Chou | Department of Orthopedics, Ditmanson Medical Foundation Chia- Yi Christian Hospital, Chia-Yi City, Taiwan | 88652765041 | james58.chou456@msa.hinet.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 17, 2021 | Apr 22, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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|
|
| BG002 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| years |
|
| Sex: Female, Male | The analysis population included all randomized participants. No participants were excluded from the analysis. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | The analysis population included all randomized participants. No participants were excluded from the analysis. | Number | Participants |
|
| body mass index | Body mass index measured at baseline prior to surgery. | Median | Inter-Quartile Range | kg/m² |
|
|
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| Primary | Pulmonary Embolism | The incidence of pulmonary embolism | Posted | Count of Participants | Participants | Up to 3 months after THR and TKR |
|
|
|
| Secondary | Complication | Major bleeding, infection, and non-healing wound | Posted | Count of Participants | Participants | Up to 3 months after THR and TKR |
|
|
|
| 75 |
| 0 |
| 75 |
| 16 |
| 75 |
| EG001 | Control | The participants are provided without antithrombotics | 0 | 75 | 0 | 75 | 12 | 75 |
|
| Symptoms of deep vein thrombosis (coldness, pain, cyanosis, swelling, or skin changes) | Vascular disorders | Systematic Assessment | Clinically assessed during hospitalization and outpatient follow-up. Symptoms included coldness, pain, cyanosis, swelling of the limb, or skin changes such as ulceration, alopecia, thinning, or inflammation. |
|
| Wound bleeding | Blood and lymphatic system disorders | Systematic Assessment | Postoperative wound bleeding observed during hospitalization, including persistent oozing from surgical site. All events were recorded prospectively by study staff. |
|
| Bruising | Skin and subcutaneous tissue disorders | Systematic Assessment | Postoperative bruising at the surgical site noted during hospitalization or outpatient follow-up. All events were recorded prospectively |
|
| Pulmonary embolism | Vascular disorders | Systematic Assessment | All randomized participants were monitored prospectively from surgery until 3-month postoperative follow-up. |
|
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| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |