RIVACAST - RIVAroxaban versus low-molecular weight heparin in patients with lower limb trauma requiring brace or CASTing
- Conditions
- ower limb trauma requiring immobilisationMedDRA version: 21.1Level: LLTClassification code: 10062618Term: Joint immobilization Class: 10042613MedDRA version: 21.1Level: PTClassification code: 10060788Term: Joint stabilisation Class: 100000004865MedDRA version: 20.0Level: SOCClassification code: 10042613Term: Surgical and medical procedures Class: 25Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- CTIS2023-509905-62-00
- Lead Sponsor
- Centre Hospitalier Universitaire D'Angers
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1424
Age = 18 years, Consultation in one of the Emergency Departments of the participating centres, Lower limb injury requiring rigid or semi-rigid orthopaedic immobilisation, Intended duration of orthopaedic immobilisation of 2 weeks or more, Intended duration of hospitalization of 72 hours or less, TRiP(cast) score = 7, Full insurance cover, Signed and dated free informed consent
Active bleeding or high risk of bleeding, Contra-indication to Rivaroxaban or LMWH, Any anticoagulant or antiplatelet treatment prior to trauma (only antiaggregant treatment authorized: aspirin < 325mg/day), Pregnant or breastfeeding woman, Factors rendering 3-month follow-up impossible, Participation in any interventional study which modifies patient care or could influence study evaluation criteria
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method