Shorter anticoagulation after hip surgery to prevent blood clots

ENhanced Recovery and ABbreviated LEngth of Anticoagulation for Thromboprophylaxis After Primary Hip Arthroplasty

This study is testing if a shorter 10-day treatment with a blood thinner after hip surgery can prevent blood clots just as well as the usual 35-day treatment for patients recovering from the surgery.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 2932 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Johannes Gutenberg University Mainz (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 6 sites (Linz, Upper Austria and 5 other locations)
• Trial ID: NCT06611319 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 scheduled for elective unilateral primary THA and who are eligible for enhanced recovery after surgery protocols.

Not a fit: Patients who are not undergoing elective unilateral primary THA or those with contraindications to anticoagulation therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a safer and more efficient postoperative care protocol, reducing the duration of anticoagulation therapy without compromising patient safety.

How similar studies have performed: Other studies have explored anticoagulation duration in various surgical settings, but this specific approach of comparing short versus standard duration in THA is novel.

Eligibility criteria

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 this trial is running

Linz, Upper Austria and 5 other locations

• 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.

Conditions: Hip Arthroplasty, Total, Prevention of Venous Thromboembolism, Thromboprophylaxis after hip surgery, Rivaroxaban, Abbreviated length of Anticoagulation, Enhanced recovery after surgery, Fast-track surgery, Early mobilization