Phase
Condition
Venous Thrombosis
Venous Thromboembolism
Blood Clots
Treatment
Prevention of Venous Thromboembolism
Placebo Oral Tablet
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Written informed consent
Age between 18 and 85 years
Scheduled to undergo elective unilateral primary THA and eligible for perioperativemanagement based on the ERAS protocol
Baseline Timed Up and Go (TUG) test scoring < 20 seconds, corresponding to agood mobility status before surgery
Capability to understand and comply with the protocol requirements (e.g., sufficientknowledge of German language to answer the questionnaires, ability to swallow intactcapsules).
Pregnancy and contraception:
Pregnancy test: Negative serum pregnancy test at screening for women ofchildbearing potential (WOCBP).
Contraception: WOCBP and men who are able to father a child, willing to beabstinent or use highly effective methods of birth control that result in a lowfailure rate of less than 1% per year when used consistently and correctlybeginning at informed consent, for the duration of drug treatment and allowingfor a safe wash out period of at least 5 days for female or for male subjectsafter the last dose of trial medication. This is a very conservative estimate,considering the 'worst case scenario' of a substantially prolonged half-life upto 13 hours (e.g., in older patients and/or those with renal dysfunction) (28),and calculating for at least 8 half-lives to ensure practically non-detectablelevels and effects of rivaroxaban.
Exclusion
Exclusion Criteria:
Previous DVT or PE
Hip or lower limb fracture in the previous three months
Major surgical procedure within the previous three months
Active cancer defined as metastatic cancer, or cancer requiring chemotherapy orradiation therapy
Active peptic ulcer disease, gastritis, or prior gastrointestinal bleeding
Obesity with body mass index (BMI) > 40 kg/m2 body surface area
Severe renal impairment defined as estimated glomerular filtration rate < 30ml/min
Severe hepatic impairment defined as Child Pugh Class B or C
Uncontrolled intercurrent illness (i.e., active infection, symptomatic congestiveheart failure, uncontrolled hypertension, unstable angina pectoris, interstitiallung disease, serious gastrointestinal conditions [e.g., diarrhea, malabsorption],psychiatric illness)
Active or recent major bleeding at any site, or presence of any major risk factorfor bleeding, which, in the judgment of the investigator, may significantly increasethe bleeding risk during postoperative anticoagulation treatment
Any other medical condition representing a contraindication to discharge within 6days after surgery
Expected requirement for major surgery within a 90-day period post THA
Need for long-term anticoagulation (e.g., atrial fibrillation, previous VTE)
Need for chronic antiplatelet therapy except for acetylsalicylic acid (ASA) at adose ≤ 100 mg daily or clopidogrel 75 mg daily
Previous participation in this trial
Life expectancy < 6 months
Participation in another interventional clinical trial within the last 30 days priorto inclusion, unless during the observational follow-up period
History of hypersensitivity to the investigational medicinal product (IMP) or to anydrug with similar chemical structure or to any excipient present in thepharmaceutical form of the IMP
Study Design
Study Description
Connect with a study center
Kepler University Medical Center, Orthopedics and Traumatology
Linz, Upper Austria 4020
AustriaActive - Recruiting
Sana Clinics Sommerfeld, Dpt. for Surgical Orthopaedics
Kremmen, Brandenburg 16766
GermanyActive - Recruiting
GPR Rüsselsheim Health and Care Center
Rüsselsheim, Hesse 65428
GermanyActive - Recruiting
University Medical Center Mainz, Center for Orthopedics and Trauma Surgery
Mainz, Rhineland-Palatine 55131
GermanyActive - Recruiting
University Medical Center Dresden, University Center for Orthopaedics, Trauma & Plastic Surgery
Dresden, Saxony 01307
GermanyActive - Recruiting
Evangelical Forest Hospital Berlin - Orthopaedics and Trauma Surgery
Berlin, 13589
GermanyActive - Recruiting
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