Early access
Sign in
Taking peoplePhase 3

Rivaroxaban compared with heparin injections to prevent blood clots after leg injury

Compares rivaroxaban with heparin for preventing clots in adults with immobilised leg injuries.

Key facts

Who runs it
University Hospital, Angers
Where
France37 sites in 1 countryChoose a country to see its sites
Registry title
RIVAroxaban Versus Low-molecular Weight Heparin in Patients With Lower Limb Trauma Requiring Brace or CASTing
Status
Recruiting
Phase
Phase 3
People taking part
1,424 people, planned
Started
19 Jul 2024
Expected to end
19 Nov 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Rivaroxaban 10 MG
  • Low Heparin Molecular Weight
Record updated
25 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults seen in an emergency department with a lower leg or foot injury that needs a cast or brace. They must have a high risk of blood clots (TRiP(cast) score ≥ 7).

Age
18 years or older
Sex
All
Disease stage
Injury to the lower limb that needs a rigid or semi-rigid cast or brace, expected to last at least 2 weeks.
Earlier treatment
People cannot join if they took any blood thinner or antiplatelet drug before the injury. Aspirin below 325mg/d is allowed.
Biomarker or test result
TRiP(cast) score ≥ 7 (a score of blood clot risk)

Main reasons for not taking part

  • Needing a hospital stay after the emergency visit for a reason other than the leg injury
  • Active bleeding or high risk of bleeding
  • Known reason they cannot take rivaroxaban or LMWH
  • Pregnant or breastfeeding
  • Unable to attend the 3-month follow-up

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Active bleeding or high risk of bleeding,
  • Patient that have to be hospitalized after emergency department for other reason than lower limb trauma
  • 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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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-risk patients. Direct oral anticoagulants, and in particular rivaroxaban, may be an effective and safe alternative to LMWH. In the PRONOMOS study, comparing LMWH with rivaroxaban in patients who had undergone non-major lower limb surgery, the relative risk of symptomatic VTE was 0.25 (95% CI = 0.09 - 0.75) in favor of rivaroxaban 10mg. No significant increase in bleeding was found. In addition, as LMWH treatment requires subcutaneous daily injections, the use of rivaroxaban may positively impact patients' quality of life as well as being effective in medico-economic terms.

Read full original descriptionShow less

The aims of this study are to demonstrate that rivaroxaban is at least as effective, easier to use and more efficient than LMWH in patients with trauma to the lower limb requiring immobilisation and deemed to be at risk of venous thromboembolism (TRiP(cast) score ≥ 7). High-risk patients are randomized to receive either rivaroxaban or LMWH. They are followed up at 45 days and 90 days to assess the occurrence of thrombotic events or bleeding, as well as their satisfaction with the treatment received.

The 2 groups in the trial

  • Rivaroxaban armTreatment being tested

    Treatment: Rivaroxaban 10 MG

  • Low-molecular-weight heparin armExisting treatment, for comparison

    Treatment with LMWH is the standard-of-care in this population of lower limb trauma patients at risk of thrombosis. The control group is therefore the group of patients who receive prophylactic anticoagulant treatment with LMWH for the duration of immobilization (i.e. until full mobilization with weight-bearing).

    Treatment: Low Heparin Molecular Weight

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
RIVACAST : RIVAroxaban Versus Low-molecular Weight Heparinin Patients With Lower Limb Trauma Requiring Brace or CASTing
Plain-language title
Rivaroxaban compared with heparin injections to prevent blood clots after leg injuryGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
25 June 2026