What is rivaroxaban studying for prevention of blood clots after hip replacement?

Rivaroxaban is being studied to compare a shorter 10-day versus the standard 35-day course of blood-thinning treatment after total hip arthroplasty. Researchers want to find out if the shorter treatment can prevent dangerous clots while reducing medication days. This trial is led by Prof. Stavros Konstantinides and aims to improve care guidelines for hip surgery patients.

Who may be eligible for this hip arthroplasty clinical trial?

Adults aged 18 to 85 scheduled for elective primary total hip arthroplasty who have good mobility and can follow study procedures may be eligible. Both men and women can join, provided they can use effective birth control during the study if applicable. Please review eligibility criteria for more details.

Is there any cost to participate in this hip arthroplasty clinical trial?

Study-related care, including the anticoagulant medication and all trial visits, is provided at no cost. Personal expenses such as travel may vary and are not guaranteed to be covered. Participants can expect trial visits and medication supplied without charge.

Actively Recruiting

Phase 3

Age: 18Years - 85Years

All Genders

ID06611319

Short versus Standard Duration of Anticoagulation Using Rivaroxaban After Elective Primary Total Hip Replacement Surgery

Led by Prof. Stavros Konstantinides, MD · Updated on 2025-01-16

2932

Participants Needed

Research Sites

17 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to determine the best duration of blood-thinning medication after elective total hip arthroplasty THA to prevent blood clots. The study compares a shorter 10-day course versus the standard 35-day course of anticoagulation after hip replacement surgery. It focuses on patients eligible for early mobilization and evaluates whether the shorter treatment is as effective at preventing dangerous clots within 90 days after surgery. The trial randomly assigns patients to one of two groups one receiving the anticoagulant rivaroxaban from day 3 to day 10 post-surgery followed by placebo until day 35, and the other receiving rivaroxaban continuously for 35 days. Both groups follow a standard enhanced recovery protocol with early mobilization after surgery. This double-blind study includes an initial two-day open-label anticoagulation period before randomization. Participants will have follow-up visits on day 35 and day 90 after surgery to monitor for blood clots, bleeding events, and overall recovery. Researchers will assess outcomes including symptomatic deep vein thrombosis, pulmonary embolism, hospital stay length, joint function, and quality of life. Safety and any adverse events will be closely tracked during these visits to understand the benefits and risks of shorter anticoagulation treatment after hip replacement.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 85Years

All Genders

Eligibility Criteria

You may qualify if you...

Written informed consent
Age between 18 and 85 years
Scheduled to undergo elective unilateral primary total hip arthroplasty
Eligible for perioperative management based on the enhanced recovery after surgery (ERAS) protocol
Baseline Timed Up and Go test scoring less than 20 seconds indicating good mobility
Ability to understand and comply with protocol requirements, including sufficient German language skills and ability to swallow capsules
Negative serum pregnancy test for women of childbearing potential at screening
Willingness of women of childbearing potential and men able to father a child to use effective birth control or abstain during study drug treatment and washout period

You will not qualify if you...

History of previous deep vein thrombosis or pulmonary embolism
Hip or lower limb fracture in the previous three months
Major surgery within the previous three months
Active metastatic cancer or cancer requiring chemotherapy or radiation
Active peptic ulcer disease, gastritis, or prior gastrointestinal bleeding
Obesity with body mass index over 40 kg/m2
Severe renal impairment (estimated glomerular filtration rate less than 30 ml/min)
Severe liver impairment (Child Pugh Class B or C)
Uncontrolled illness such as active infection, heart failure, uncontrolled hypertension, unstable angina, interstitial lung disease, serious gastrointestinal conditions, or psychiatric illness
Active or recent major bleeding or significant bleeding risk
Medical conditions preventing discharge within 6 days after surgery
Expected need for major surgery within 90 days after hip arthroplasty
Need for long-term anticoagulation therapy
Need for chronic antiplatelet therapy except low-dose aspirin or clopidogrel
Previous participation in this trial
Life expectancy less than 6 months
Participation in another interventional trial within 30 days prior to inclusion
Known hypersensitivity to the investigational drug or related compounds

Research Team

Nadine Martin, Dr.

Susanne Fischer, M.Sc.

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Short versus Standard Duration of Anticoagulation Using Rivaroxaban After Elective Primary Total Hip Replacement Surgery

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria