RIVAroxaban Versus Low-molecular Weight Heparin in Patients With Lower Limb Trauma Requiring Brace or CASTing

Launched by UNIVERSITY HOSPITAL, ANGERS · Dec 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how well a medication called rivaroxaban works compared to a commonly used treatment known as low-molecular weight heparin (LMWH) for patients who have had trauma to their lower limbs and need to be immobilized, like in a cast or brace. Patients who are considered at high risk for developing blood clots (venous thromboembolism) will be involved in this study. To be eligible, participants must be at least 18 years old, have a TRiP(cast) score of 7 or higher (which indicates a higher risk for blood clots), and require at least two weeks of immobilization due to their injury.

If you decide to participate, you will be randomly assigned to receive either rivaroxaban or LMWH for your treatment. After starting the medication, you will have follow-up visits at 45 and 90 days to check for any blood clot events or bleeding, as well as to see how satisfied you are with the treatment. This trial aims to find out if rivaroxaban is not only as effective as LMWH but also easier to take, since LMWH requires daily injections, while rivaroxaban is taken as a pill. Your participation could help improve treatment options for future patients with similar injuries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient aged 18 or over ;
• • Consultation in an emergency department of a participating centre;
• • Trauma to the lower limb requiring rigid or semi-rigid orthopaedic immobilisation;
• • Expected duration of orthopaedic immobilisation of at least 2 weeks;
• • TRiP(cast) score ≥ 7 ;
• • Patient affiliated to or benefiting from a social security scheme;
• • Patient with prior informed consent.
• Exclusion Criteria:
• • Patient that have to be hospitalized after emergency department for other reason than lower limb trauma
• • Active bleeding or high risk of bleeding,
• • Known contraindication to rivaroxaban or LMWH;
• • Taking any anticoagulant or antiplatelet agent before the trauma (only antithrombotic authorised: aspirin \< 325mg/d);
• • Pregnant or breastfeeding woman;
• • Any factor making 3-month follow-up impossible; 6. Patient subject to a legal protection measure, Imprisonment 7. Participation in any interventional study which modifies patient care or could influence study evaluation criteria