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

MI-összefoglaló

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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).

Életkor

18 years or older

Nem

All

A betegség stádiuma

Injury to the lower limb that needs a rigid or semi-rigid cast or brace, expected to last at least 2 weeks.

Korábbi kezelés

People cannot join if they took any blood thinner or antiplatelet drug before the injury. Aspirin below 325mg/d is allowed.

Biomarker vagy leletérték

TRiP(cast) score ≥ 7 (a score of blood clot risk)

A részvétel fő kizáró okai

• 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

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

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.

A vizsgálat 2 csoportja

• Rivaroxaban armA vizsgált kezelés

  Kezelés: Rivaroxaban 10 MG

• Low-molecular-weight heparin armMár használt kezelés, összehasonlításként

  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).

  Kezelés: Low Heparin Molecular Weight