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Study identifier: NCT06195540 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Venous Thromboembolism · Deep Vein Thrombosis · Pulmonary Embolism  ·  Sponsor: University Hospital, Angers

PhasePhase 3
Planned participants1424
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 stud…

This description comes directly from the study's public registry record.

Talk to the study team

Delphine Douillet, Doctor  ·  0241353637  ·  Delphine.Douillet@chu-angers.fr

Cindy Augereau, Mrs  ·  0241354143  ·  Cindy.Augereau@chu-angers.fr

Always discuss trial participation with your own doctor first.

Locations (37)

Agen-Nerac Hospital, Emergency DepartmentAgen, FranceActive Not Recruiting
Angers University Hospital, Emergency departmentAngers, FranceRecruiting
Argenteuil hospital, Emergency departmentArgenteuil, FranceRecruiting
Arpajon Hospital, Emergency DepartmentArpajon, FranceWithdrawn
Caen University hospital, Emergency departmentCaen, FranceWithdrawn
Tours University Hospital, Emergency departmentChambray-lès-Tours, FranceWithdrawn
Cholet Hospital, Emergency departmentCholet, FranceRecruiting
Clermont-Ferrand University Hospital, Emergency departmentClermont-Ferrand, FranceRecruiting
Simone Veil Hospital, Emergency DepartmentEaubonne, FranceRecruiting
Eure-Seine Hospital, Emergency DepartementÉvreux, FranceActive Not Recruiting
Grenoble University Hospital, Emergency DepartmentGrenoble, FranceRecruiting
La Roche sur Yon HospitalLa Roche-sur-Yon, FranceNot Yet Recruiting

+ 25 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06195540