Clinical trial NCT05449327: Xarelto for Thromboprophylaxis After Total Hip and Total Knee Arthroplasty
Official title: Xarelto for Thromboprophylaxis After Total Hip and Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Venous Thromboembolism
Arthroplasty
Lead sponsor: Chiayi Christian Hospital
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 178
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Deep vein thrombosis
timeFrame: Up to 3 months after THR and TKR
measure: Pulmonary embolism
timeFrame: Up to 3 months after THR and TKR
Secondary outcomes:
measure: Complication
timeFrame: Up to 3 months after THR and TKR
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: Ditmanson Medical Foundation Chiayi Christian Hospital
Study officials:
References: