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

RecruitingPhase 3Ages 18 Years - anyAllUniversity Hospital, Angers
NCT06195540 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Lower limb trauma requiring immobilization is a very frequent condition that is associated with an increased risk of developing venous thromboembolism (VTE). The TRiP(cast) score has been developed to provide individual VTE risk stratification and help in thromboprophylactic anticoagulation decision. The recent CASTING study had confirmed that patients with a TRiP(cast) score \<7 have a very low risk of VTE and could be safely manage without prophylactic treatment. Conversely, patients with a score ≥ 7 have a high-risk of VTE and require a prophylactic anticoagulant treatment. Low molecular weight heparins (LMWH) have been shown to be effective in this indication. However, in the CASTING study, the 3-month symptomatic VTE rate was 2.6% in this subgroup despite LMWH prophylactic treatment. This result suggests that LMWH are not sufficiently effective in this particular subgroup of high-ri

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📋 Eligibility rules (as published)
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
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What it tests

  • Rivaroxaban 10 MG
  • Low Heparin Molecular Weight
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Where

37 sites
Agen-Nerac Hospital, Emergency Department
Agen, France
Angers University Hospital, Emergency department
Angers, France
Argenteuil hospital, Emergency department
Argenteuil, France
Arpajon Hospital, Emergency Department
Arpajon, France
Caen University hospital, Emergency department
Caen, France
Tours University Hospital, Emergency department
Chambray-lès-Tours, France
Cholet Hospital, Emergency department
Cholet, France
Clermont-Ferrand University Hospital, Emergency department
Clermont-Ferrand, France

…and 29 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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