Status:
RECRUITING
RIVAroxaban Versus Low-molecular Weight Heparin in Patients With Lower Limb Trauma Requiring Brace or CASTing
Lead Sponsor:
University Hospital, Angers
Conditions:
Venous Thromboembolism
Deep Vein Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 19 2026
Estimated Enrollment :
1424 Patients enrolled
Trial Details
Trial ID
NCT06195540
Start Date
July 19 2024
End Date
November 19 2026
Last Update
December 8 2025
Active Locations (35)
Enter a location and click search to find clinical trials sorted by distance.
1
Agen-Nerac Hospital, Emergency Department
Agen, France, 47923
2
Angers University Hospital, Emergency department
Angers, France, 49000
3
Argenteuil hospital, Emergency department
Argenteuil, France, 95100
4
Arpajon Hospital, Emergency Department
Arpajon, France, 91294