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

Official title

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

Overview

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. 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.

Interventions

• Drug Rivaroxaban 10 MG
  Administration of rivaroxaban 10 mg once daily to prevent venous thromboembolic events in patients with trauma to a lower limb. Consecutive patients with lower limb trauma and a TRiP(cast) score ≥ 7 are assessed for possible participation in the study. At the inclusion visit, if the patient meets the study's selection criteria, the investigator provides oral and written information (information letter written in a language the patient can understand) and answers any questions the patient may ha
• Drug Low Heparin Molecular Weight
  Administration of standard prophylactic anticoagulant treatment with LMWH for the duration of immobilisation (i.e. until full mobilisation with weight-bearing). Consecutive patients with lower limb trauma and a TRiP(cast) score ≥ 7 are assessed for possible participation in the study. At the inclusion visit, if the patient meets the study's selection criteria, the investigator provides oral and written information (information letter written in a language the patient can understand) and answers

Primary outcome measures

• Rate of symptomatic venous thromboembolic events (45 days non-inferiority) [Time frame: 45 days]

Secondary outcome measures (5)

• Patient self reported treatment satisfaction [Time frame: 45 days]
• Rate of symptomatic venous thromboembolic events (90 days superiority) [Time frame: 90 days]
• Cumulative rates of major bleeding and of non-major clinically relevant bleeding (90 days) [Time frame: 90 days]
• Incremental cost-utility ratio (rivaroxaban efficiency 45 days) [Time frame: 45 days]
• Incremental cost-utility ratio (rivaroxaban efficiency 90 days) [Time frame: 90 days]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

France · 37 centers

• Agen-Nerac Hospital, Emergency Department — Agen
• Angers University Hospital, Emergency department — Angers
• Argenteuil hospital, Emergency department — Argenteuil
• Arpajon Hospital, Emergency Department — Arpajon
• Caen University hospital, Emergency department — Caen
• Tours University Hospital, Emergency department — Chambray-lès-Tours
• Cholet Hospital, Emergency department — Cholet
• Clermont-Ferrand University Hospital, Emergency department — Clermont-Ferrand
• … and 29 more centers

Identifiers

NCT: NCT06195540 · 49RC21_0376 · 2023-509905-62-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗