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

Status: Recruiting
Location: See all (33) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Agen-Nerac Hospital, Emergency Department
NOT_YET_RECRUITING
Agen
Angers University Hospital, Emergency department
RECRUITING
Angers
Argenteuil hospital, Emergency department
RECRUITING
Argenteuil
Arpajon Hospital, Emergency Department
NOT_YET_RECRUITING
Arpajon
Caen University hospital, Emergency department
WITHDRAWN
Caen
Tours University Hospital, Emergency department
NOT_YET_RECRUITING
Chambray-lès-tours
Cholet Hospital, Emergency department
RECRUITING
Cholet
Clermont-Ferrand University Hospital, Emergency department
RECRUITING
Clermont-ferrand
Simone Veil Hospital, Emergency Department
RECRUITING
Eaubonne
Eure-Seine Hospital, Emergency Departement
NOT_YET_RECRUITING
Évreux
Grenoble University Hospital, Emergency Department
RECRUITING
Grenoble
La Rochelle Hospital, Adult emergency departement
NOT_YET_RECRUITING
La Rochelle
Le Mans Hospital, Emergency department
RECRUITING
Le Mans
Limoges University hospital, Emergency department
RECRUITING
Limoges
Edouard Herriot University Hospital, Emergency Department
RECRUITING
Lyon
Marseille University Hospital, Emergency department
NOT_YET_RECRUITING
Marseille
Montpellier University Hospital, emergency department
RECRUITING
Montpellier
Nantes University Hospital, Emergency department
RECRUITING
Nantes
Nice University Hospital, Emergency department
WITHDRAWN
Nice
Niort Hospital, Emergency Department
RECRUITING
Niort
Bichat Hospital, Adult Emergency department
NOT_YET_RECRUITING
Paris
Cochin Hospital, Emergency department
RECRUITING
Paris
HEGP, Emergency Department
RECRUITING
Paris
La Pitié-Salpétrière Hospital, Emergency Department
NOT_YET_RECRUITING
Paris
Lariboisière hospital, emergency department
NOT_YET_RECRUITING
Paris
Saint-Antoine Hospital, Emergency department
RECRUITING
Paris
St-Joseph Hospital, Emergency Department
RECRUITING
Paris
South Lyon University Hospital, Emergency department
RECRUITING
Pierre-bénite
Poitiers University Hospital, Emergency department
RECRUITING
Poitiers
Rennes University Hospital, Emergency department
RECRUITING
Rennes
Rouen University Hospital, Emergency Department
NOT_YET_RECRUITING
Rouen
Strasbourg University Hospital, Emergency Department
RECRUITING
Strasbourg
Toulouse University Hospital, Emergency Department
RECRUITING
Toulouse
Contact Information
Primary
Delphine Douillet, Doctor
Delphine.Douillet@chu-angers.fr
0241353637
Backup
Cindy Augereau, Mrs
Cindy.Augereau@chu-angers.fr
0241354143
Time Frame
Start Date: 2024-07-19
Estimated Completion Date: 2026-11-19
Participants
Target number of participants: 1424
Treatments
Experimental: Rivaroxaban arm
Active_comparator: Low-molecular-weight heparin arm
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).
Sponsors
Leads: University Hospital, Angers

This content was sourced from clinicaltrials.gov