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Study on Shortened Anticoagulation with Rivaroxaban for Blood Clot Prevention in Patients Undergoing Hip Replacement Surgery

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients who are undergoing a planned hip replacement surgery, known as hip arthroplasty. The study is examining the use of a medication called Rivaroxaban, which is a type of blood thinner, to prevent blood clots after surgery. Blood clots can lead to serious conditions like deep vein thrombosis (DVT) or pulmonary embolism (PE). The trial will compare a shorter treatment period of 10 days with the usual 35-day treatment to see if the shorter period is just as effective in preventing these complications.

Participants in the study will receive either the medication Rivaroxaban or a placebo, which looks like the medication but does not contain the active ingredient. The study aims to find out if the shorter duration of taking Rivaroxaban is as safe and effective as the longer duration. The trial will monitor for any signs of blood clots, as well as other health outcomes such as overall recovery, any serious side effects, and the need for additional hospital visits.

The study will follow participants for up to 90 days after they join to track their recovery and any health issues that arise. This research is important to potentially reduce the length of time patients need to take blood thinners after hip surgery, which could lead to fewer side effects and a quicker return to normal activities.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after providing written informed consent.

    Eligibility includes being between 18 and 85 years old, scheduled for a primary hip replacement, and meeting specific health criteria.

  2. Step 2

    Surgery preparation

    Preparation follows the Enhanced Recovery after Surgery (ERAS) protocol, which is a plan to help recover quickly after surgery.

    A baseline mobility test, called the Timed Up and Go (TUG) test, is conducted to assess mobility before surgery.

  3. Step 3

    Surgery and initial recovery

    Undergo elective unilateral primary hip arthroplasty, which is a planned hip replacement surgery.

    Initial recovery involves following the ERAS protocol to enhance recovery.

  4. Step 4

    Medication administration

    Receive a direct oral anticoagulant (DOAC) called Rivaroxaban in the form of hard gelatin capsules.

    The medication is taken orally for 10 days to prevent blood clots, which is shorter than the standard 35-day duration.

  5. Step 5

    Monitoring and follow-up

    Monitoring for any symptoms of venous thromboembolism (VTE), which includes blood clots in the veins or lungs, for 90 days after joining the study.

    Regular assessments of mobility, quality of life, and any adverse events.

  6. Step 6

    Completion of study participation

    Participation concludes after the 90-day monitoring period.

    Final assessments include checking for any health changes and overall recovery status.

Who can join the trial?

6 criteria

  • Provide written informed consent, which means you agree to participate in the study after being fully informed about it.
  • Be between the ages of 18 and 85 years.
  • Be scheduled to have a planned surgery called elective unilateral primary THA (total hip arthroplasty) and be eligible for a special recovery plan called the ERAS protocol (Enhanced Recovery after Surgery).
  • Have a Timed Up and Go (TUG) test score of less than 20 seconds, which shows you have good mobility before the surgery. This test measures how quickly you can stand up from a chair, walk a short distance, and sit down again.
  • Be able to understand and follow the study requirements, such as having enough knowledge of the German language to answer questions and being able to swallow capsules whole.
  • If you are a woman, have a negative serum pregnancy test and use a highly effective method of birth control during the study treatment.
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Investigated drugs

Direct Oral Anticoagulant (DOAC) is a type of medication used to prevent blood clots. In this trial, it is being tested to see if a shorter duration of use after hip surgery is as effective as the longer, standard duration. The goal is to prevent conditions like deep vein thrombosis (DVT) and pulmonary embolism (PE), which are types of blood clots that can occur after surgery.

What is already known about the treatment

Direct Oral Anticoagulant (DOAC) – This medication is administered orally and is used to prevent blood clots in patients undergoing hip replacement surgery. It is currently being studied in clinical trials to determine if a shorter duration of use is as effective as the standard longer duration. The main therapeutic indication is to prevent venous thromboembolism, which includes conditions like deep vein thrombosis and pulmonary embolism. At the molecular level, DOACs work by directly inhibiting specific clotting factors in the blood, which helps to prevent the formation of clots. They are classified as anticoagulants, specifically targeting the coagulation cascade to reduce the risk of clot-related complications.

Investigated diseases

Venous Thromboembolism (VTE) – This condition involves the formation of blood clots in the veins, which can lead to serious complications. It primarily includes two types: deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT occurs when a blood clot forms in a deep vein, usually in the legs, causing pain and swelling. If a part of the clot breaks off, it can travel to the lungs and cause a PE, which can lead to difficulty breathing and chest pain. VTE can develop after surgery, especially in patients with limited mobility. Preventive measures are often taken to reduce the risk of clot formation.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507490-18-00Protocol code23-01496Estimated enrolment5 000 patientsSponsorUniversitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

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