Home › Trials › NCT06195540

Comparing rivaroxaban and low-molecular weight heparin for preventing blood clots in patients with lower limb trauma

RIVACAST : RIVAroxaban Versus Low-molecular Weight Heparinin Patients With Lower Limb Trauma Requiring Brace or CASTing

Phase 3 Interventional University Hospital, Angers · NCT06195540

This study is testing if a new blood thinner called rivaroxaban can prevent blood clots better than a standard treatment in patients with leg injuries who are at high risk for clots.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1424 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity Hospital, Angers Government
Locations35 sites (Agen and 34 other locations)
Trial IDNCT06195540 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of rivaroxaban compared to low-molecular weight heparin (LMWH) in preventing venous thromboembolism (VTE) in patients with lower limb trauma requiring immobilization. Patients with a TRiP(cast) score of 7 or higher, indicating a high risk for VTE, will be randomly assigned to receive either rivaroxaban or LMWH for thromboprophylaxis. The study aims to determine if rivaroxaban can reduce the incidence of VTE more effectively than LMWH in this specific patient population. The trial is conducted in emergency departments across multiple hospitals.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 or older with lower limb trauma requiring immobilization and a TRiP(cast) score of 7 or higher.

Not a fit: Patients who are hospitalized for reasons other than lower limb trauma or those with active bleeding or contraindications to the study medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective anticoagulation option for patients at high risk of VTE following lower limb trauma.

How similar studies have performed: Previous studies have indicated that LMWH is effective for VTE prophylaxis, but this trial is exploring a novel approach with rivaroxaban in a high-risk subgroup.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Agen and 34 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Venous ThromboembolismDeep Vein ThrombosisPulmonary EmbolismLower Limb TraumaThromboprophylaxisImmobilisationEmergency departmentdirect oral anticoagulant
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.