Xarelto for Thromboprophylaxis After Total Hip and Total Knee Arthroplasty

Venous Thromboembolism Clinical Trial

Official title:

Xarelto for Thromboprophylaxis After Total Hip and Total Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05449327
• Other study ID #: IRB2021079
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 21, 2025

Study information

• Verified date: October 2023
• Source: Chiayi Christian Hospital
• Contact: Cheng-Ming Chou
• Phone: 88652765041
• Email: james58.chou456[@]msa.hinet.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: December 21, 2025
• Est. primary completion date: December 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Rivaroxaban 10 MG
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.

Locations

Country	Name	City	State
Taiwan	Ditmanson Medical Foundation Chiayi Christian Hospital	Chiayi City

Sponsors (1)

Lead Sponsor	Collaborator
Chiayi Christian Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Deep vein thrombosis	The incidence of both asymptomatic and symptomatic deep vein thrombosis	Up to 3 months after THR and TKR
Primary	Pulmonary embolism	The incidence of pulmonary embolism	Up to 3 months after THR and TKR
Secondary	Complication	Major bleeding, infection, and non-healing wound	Up to 3 months after THR and TKR