Shorter anticoagulation after hip surgery to prevent blood clots

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of a shorter duration of anticoagulation therapy using Rivaroxaban for patients undergoing elective total hip arthroplasty (THA). It compares a 10-day regimen of postoperative anticoagulation to the standard 35-day regimen to determine if the shorter duration is equally effective in preventing venous thromboembolism (VTE). The study follows an enhanced recovery protocol to facilitate early mobilization of patients after surgery. It aims to provide solid evidence regarding the optimal duration of thromboprophylaxis in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Written informed consent
2. Age between 18 and 85 years
3. Scheduled to undergo elective unilateral primary THA and eligible for perioperative management based on the ERAS protocol
4. Baseline Timed Up and Go (TUG) test scoring \< 20 seconds, corresponding to a good mobility status before surgery
5. 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).
6. Pregnancy and contraception:

   1. Pregnancy test: Negative serum pregnancy test at screening for women of childbearing potential (WOCBP).
   2. 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 Criteria:

1. Previous DVT or PE
2. Hip or lower limb fracture in the previous three months
3. Major surgical procedure within the previous three months
4. Active cancer defined as metastatic cancer, or cancer requiring chemotherapy or radiation therapy
5. Active peptic ulcer disease, gastritis, or prior gastrointestinal bleeding
6. Obesity with body mass index (BMI) \> 40 kg/m2 body surface area
7. Severe renal impairment defined as estimated glomerular filtration rate \< 30ml/min
8. Severe hepatic impairment defined as Child Pugh Class B or C
9. 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)
10. 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
11. Any other medical condition representing a contraindication to discharge within 6 days after surgery
12. Expected requirement for major surgery within a 90-day period post THA
13. Need for long-term anticoagulation (e.g., atrial fibrillation, previous VTE)
14. Need for chronic antiplatelet therapy except for acetylsalicylic acid (ASA) at a dose ≤ 100 mg daily or clopidogrel 75 mg daily
15. Previous participation in this trial
16. Life expectancy \< 6 months
17. Participation in another interventional clinical trial within the last 30 days prior to inclusion, unless during the observational follow-up period
18. 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

Where it's running

• Kepler University Medical Center, Orthopedics and Traumatology
  Linz, Upper Austria, Austria Recruiting
• Sana Clinics Sommerfeld, Dpt. for Surgical Orthopaedics
  Kremmen, Brandenburg, Germany Recruiting
• GPR Rüsselsheim Health and Care Center
  Rüsselsheim am Main, Hesse, Germany Recruiting
• University Medical Center Mainz, Center for Orthopedics and Trauma Surgery
  Mainz, Rhineland-Palatine, Germany Recruiting
• University Medical Center Dresden, University Center for Orthopaedics, Trauma & Plastic Surgery
  Dresden, Saxony, Germany Recruiting
• Evangelical Forest Hospital Berlin - Orthopaedics and Trauma Surgery
  Berlin, Germany Recruiting

Study contacts

• Study coordinator: Nadine Martin, Dr.
• Email: nadine.martin@unimedizin-mainz.de
• Phone: +496131178376

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.