Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05449327
Other study ID # IRB2021079
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05347550 - Examining the Benefit of Graduated Compression Stockings in the Prevention of vEnous Thromboembolism in Low-risk Surgical Patients N/A
Enrolling by invitation NCT05794165 - Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism Phase 2
Completed NCT02379806 - The SYMPTOMS - SYstematic Elderly Medical Patients Thromboprophylaxis: Efficacy on Symptomatic OutcoMeS - Study Phase 3
Recruiting NCT03691753 - Safety and Efficacy Study of Fitaya Vena Cava Filter N/A
Completed NCT02197416 - Safety of Dabigatran Etexilate in Blood Clot Prevention in Children Phase 3
Recruiting NCT05378035 - DOAC in Chinese Patients With Atrial Fibrillation
Recruiting NCT05171075 - A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE Phase 3
Completed NCT01895777 - Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE) Phase 3
Completed NCT05897697 - Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
Completed NCT04736719 - Replication of the AMPLIFY Anticoagulant Trial in Healthcare Claims Data
Completed NCT04735523 - Replication of the RECOVER-II Anticoagulant Trial in Healthcare Claims Data
Completed NCT04736420 - Replication of the EINSTEIN-DVT Anticoagulant Trial in Healthcare Claims Data
Completed NCT02829957 - RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding Phase 2/Phase 3
Completed NCT02746185 - Cancer Associated Thrombosis, a Pilot Treatment Study Using Rivaroxaban Phase 3
Completed NCT02912234 - Effect of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Participants Phase 1
Completed NCT02334007 - Extended Low-Molecular Weight Heparin VTE Prophylaxis in Thoracic Surgery Phase 1/Phase 2
Completed NCT02661568 - Description of Patients With Acute Venous Thromboembolism in the UK's Clinical Practice Research Datalink Linked With Hospital Episode Statistics Dataset (CPRD-HES) N/A
Completed NCT02223260 - Tolerability , PK/PD and Safety of Dabigatran Etexilate Oral Liquid Formulation in Children < 1 Year of Age Phase 2
Completed NCT01431456 - Safety of DAbigatran and RIvaroxaban Versus NAdroparin in the Prevention of Venous Thromboembolism After Knee Arthroplasty Surgery Phase 3
Completed NCT01972243 - Risk of Recurrent Venous Thrombosis: A Validation Study of the Vienna Prediction Model