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Recruiting NCT06195540

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

Conditions: Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism, Lower Limb Trauma, Thromboprophylaxis, Immobilisation

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 1424
Sponsor: University Hospital, Angers

Location: Agen-Nerac Hospital, Emergency Department Agen

Summary

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 \

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06195540). StuddyBuddy aggregates publicly available trial information.