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Study Comparing Rivaroxaban and Drug Combination for Preventing Blood Clots in Patients with Lower Limb Injuries Requiring Immobilization

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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 have experienced lower limb trauma and require immobilization, such as a brace or cast. The study aims to compare the effectiveness of two treatments in preventing blood clots, which are known as thromboembolic events. The treatments being compared are Rivaroxaban, a medication taken orally in the form of a tablet, and low-molecular weight heparin (LMWH), which is administered through injections. The main goal is to determine if Rivaroxaban is not less effective than LMWH in preventing these blood clots in patients who are at high risk according to a specific score called the TRiP(cast) score.

Participants in the study will receive either Rivaroxaban or LMWH for a period of up to 50 days. The study will monitor the occurrence of any symptomatic blood clots, such as deep venous thrombosis or pulmonary embolism, within 45 days after starting the treatment. These conditions can be serious, as they involve blood clots forming in the veins or lungs, which can lead to complications if not treated effectively.

The trial is designed to ensure that both treatments are given under careful supervision, and participants will be monitored for any side effects or complications. The study will help determine the best approach to prevent blood clots in patients with lower limb injuries requiring immobilization, providing valuable information for future treatment options. Participants will be randomly assigned to receive either Rivaroxaban or LMWH, and some may receive a placebo to help compare the effectiveness of the treatments. The trial is expected to continue until September 2026.

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

    Upon joining the study, eligibility is confirmed based on criteria such as age (18 years or older), a lower limb injury requiring immobilization, and a TRiP(cast) score of 7 or higher.

    Consent is required, and it must be signed and dated.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the condition of the lower limb injury and the need for immobilization.

    The intended duration of immobilization should be at least 2 weeks, and hospitalization should not exceed 72 hours.

  3. Step 3

    Medication administration

    Participants are randomly assigned to receive either Rivaroxaban or a low-molecular weight heparin (LMWH) such as tinzaparin sodium, enoxaparin sodium, nadroparin calcium, or dalteparin sodium.

    Rivaroxaban is administered orally in the form of a 10 mg film-coated tablet.

    LMWH is administered via subcutaneous injection using pre-filled syringes.

  4. Step 4

    Treatment duration

    The treatment continues for the duration of the immobilization period, which is intended to be 2 weeks or more.

    The primary goal is to prevent symptomatic thromboembolic events, such as deep vein thrombosis or pulmonary embolism, within 45 days after inclusion.

  5. Step 5

    Follow-up and monitoring

    Regular follow-up appointments are scheduled to monitor the patient's condition and any potential side effects of the medication.

    The primary endpoint is the rate of symptomatic venous thromboembolic events within 45 days after inclusion.

  6. Step 6

    Completion of the study

    Upon completion of the study period, a final assessment is conducted to evaluate the outcomes and any occurrences of thromboembolic events.

    The study aims to demonstrate the non-inferiority of Rivaroxaban compared to LMWH in preventing these events.

Who can join the trial?

8 criteria

  • Must be 18 years or older.
  • Must have had a consultation in one of the Emergency Departments of the participating centers.
  • Must have a lower limb injury that requires a rigid or semi-rigid orthopaedic support to keep the limb still.
  • The orthopaedic support must be needed for 2 weeks or more.
  • The hospital stay should be planned for 72 hours or less.
  • Must have a TRiP(cast) score of 7 or higher. This score helps to assess the risk of blood clots.
  • Must have full insurance cover.
  • Must provide a signed and dated free informed consent, which means agreeing to participate after understanding the study details.

Who cannot join the trial?

4 criteria

  • Patients who have a **lower limb trauma** that requires **immobilization**. This means if you have an injury to your leg that needs to be kept still, you may not be able to participate.
  • Patients who are not considered at **high risk of VTE**. VTE stands for **venous thromboembolism**, which is a condition where blood clots form in the veins. If your risk score is less than 7, you may not be eligible.
  • Patients who are not within the specified **age range**. The trial is open to certain age groups, so if you are outside of these, you may not be able to join.
  • Patients who are part of a **vulnerable population**. This means if you are in a group that needs special protection, you might not be eligible.
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Investigated drugs

  • Rivaroxaban

    is a medication used to prevent blood clots. In this trial, it is being tested to see if it is as effective as another treatment in preventing blood clots in patients who have had a lower limb injury and need to wear a brace or cast. The goal is to see if it can prevent clots without causing more side effects.

  • Low-Molecular Weight Heparin (LMWH)

    is another type of medication used to prevent blood clots. It is commonly used in patients who are at high risk of developing clots, such as those with injuries requiring immobilization. In this trial, it serves as the standard treatment to compare the effectiveness and safety of Rivaroxaban.

What is already known about the treatment

Rivaroxaban – Rivaroxaban is an oral medication used to prevent blood clots in patients with lower limb trauma requiring immobilization, such as a brace or cast. It is currently being studied in clinical trials to compare its effectiveness to low-molecular-weight heparin (LMWH) for preventing thromboembolic events. Rivaroxaban works by inhibiting a specific protein in the blood called Factor Xa, which plays a crucial role in the blood clotting process. It is classified as a direct oral anticoagulant (DOAC) and is known for its ease of use compared to traditional anticoagulants, as it does not require regular blood monitoring.

Investigated diseases

Lower Limb Trauma Requiring Immobilization – This condition involves an injury to the lower limb, such as a fracture or severe sprain, that necessitates the use of a cast or brace to keep the affected area immobile. Immobilization is crucial to allow proper healing of the injured tissues, bones, or joints. During this period, the lack of movement can lead to complications such as muscle atrophy or joint stiffness. Patients may also be at increased risk for developing blood clots due to reduced mobility. The healing process can vary depending on the severity of the trauma and the individual's overall health. Regular monitoring and follow-up care are essential to ensure proper recovery and to address any complications that may arise.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509905-62-00Protocol code49RC21_0376Estimated enrolment1 424 patientsSponsorCentre Hospitalier Universitaire D'Angers

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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