Status:
RECRUITING
ENhanced Recovery and ABbreviated LEngth of Anticoagulation for Thromboprophylaxis After Primary Hip Arthroplasty
Lead Sponsor:
Prof. Stavros Konstantinides, MD
Conditions:
Hip Arthroplasty, Total
Prevention of Venous Thromboembolism
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
Surgical hip replacement (total hip arthroplasty, THA) is associated with a high risk of venous thromboembolism, but the appropriate duration of postoperative medical thromboprophylaxis ("anticoagulat...
Detailed Description
An increasing proportion of the ageing population in Europe and other parts of the world suffers from hip osteoarthritis and will need surgical joint arthroplasty at some time in their lives. Surgical...
Eligibility Criteria
Inclusion
- Written informed consent
- Age between 18 and 85 years
- Scheduled to undergo elective unilateral primary THA and eligible for perioperative management based on the ERAS protocol
- Baseline Timed Up and Go (TUG) test scoring \< 20 seconds, corresponding to a good mobility status before surgery
- Capability to understand and comply with the protocol requirements (e.g., sufficient knowledge of German language to answer the questionnaires, ability to swallow intact capsules).
- Pregnancy and contraception:
- Pregnancy test: Negative serum pregnancy test at screening for women of childbearing potential (WOCBP).
- Contraception: WOCBP and men who are able to father a child, willing to be abstinent or use highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly beginning at informed consent, for the duration of drug treatment and allowing for a safe wash out period of at least 5 days for female or for male subjects after the last dose of trial medication. This is a very conservative estimate, considering the 'worst case scenario' of a substantially prolonged half-life up to 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-detectable levels and effects of rivaroxaban.
Exclusion
- 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 or radiation 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 congestive heart failure, uncontrolled hypertension, unstable angina pectoris, interstitial lung disease, serious gastrointestinal conditions \[e.g., diarrhea, malabsorption\], psychiatric illness)
- Active or recent major bleeding at any site, or presence of any major risk factor for bleeding, which, in the judgment of the investigator, may significantly increase the bleeding risk during postoperative anticoagulation treatment
- Any other medical condition representing a contraindication to discharge within 6 days 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 a dose ≤ 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 prior to inclusion, unless during the observational follow-up period
- History of hypersensitivity to the investigational medicinal product (IMP) or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the IMP
Key Trial Info
Start Date :
November 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
2932 Patients enrolled
Trial Details
Trial ID
NCT06611319
Start Date
November 26 2024
End Date
July 1 2027
Last Update
January 16 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Kepler University Medical Center, Orthopedics and Traumatology
Linz, Upper Austria, Austria, 4020
2
Sana Clinics Sommerfeld, Dpt. for Surgical Orthopaedics
Kremmen, Brandenburg, Germany, 16766
3
GPR Rüsselsheim Health and Care Center
Rüsselsheim am Main, Hesse, Germany, 65428
4
University Medical Center Mainz, Center for Orthopedics and Trauma Surgery
Mainz, Rhineland-Palatine, Germany, 55131