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Completed

NCT Number: NCT05449327

Xarelto for Thromboprophylaxis After Total Hip and Total Knee Arthroplasty

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.

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Key information

Conditions

Venous Thromboembolism Arthroplasty Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ditmanson Medical Foundation Chiayi Christian Hospital

Chiayi City, Taiwan, 60002

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Xarelto

Primary outcomes

  1. Deep Vein Thrombosis

    Time frame: Up to 3 months after THR and TKR

    The incidence of both asymptomatic and symptomatic deep vein thrombosis

  2. Pulmonary Embolism

    Time frame: Up to 3 months after THR and TKR

    The incidence of pulmonary embolism

Secondary outcomes

  1. Complication

    Time frame: Up to 3 months after THR and TKR

    Major bleeding, infection, and non-healing wound

Sponsors and collaborators

Lead sponsor

Chiayi Christian Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 8, 2022
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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