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

PHASE3RecruitingINTERVENTIONAL
Enrollment

1,424

Participants

Timeline

Start Date

July 19, 2024

Primary Completion Date

November 19, 2026

Study Completion Date

November 19, 2026

Conditions
Venous ThromboembolismDeep Vein ThrombosisPulmonary EmbolismLower Limb TraumaThromboprophylaxisImmobilisation
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 have. Depending on randomisation, the patient will receive either LMWH or rivaroxaban. The dose is rivaroxaban 10 mg orally once a day (no dosage adjustment).~Treatment is started in the emergency department and continued at home for the duration of the immobilisation (i.e. until mobilisation with weight-bearing). The duration of treatment will be determined by the physician."

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 any questions the patient may have. Depending on randomisation, the patient will receive either LMWH or rivaroxaban. The dose of LMWH is free, given according to local practices and national recommendations.~Treatment is started in the emergency department and continued at home for the duration of the immobilisation (i.e. until mobilisation with weight-bearing). The duration of treatment will be determined by the physician."

Trial Locations (33)

13005

NOT_YET_RECRUITING

Marseille University Hospital, Emergency department, Marseille

14000

WITHDRAWN

Caen University hospital, Emergency department, Caen

17000

NOT_YET_RECRUITING

La Rochelle Hospital, Adult emergency departement, La Rochelle

27015

NOT_YET_RECRUITING

Eure-Seine Hospital, Emergency Departement, Évreux

31000

RECRUITING

Toulouse University Hospital, Emergency Department, Toulouse

34000

RECRUITING

Montpellier University Hospital, emergency department, Montpellier

35000

RECRUITING

Rennes University Hospital, Emergency department, Rennes

37170

NOT_YET_RECRUITING

Tours University Hospital, Emergency department, Chambray-lès-Tours

38000

RECRUITING

Grenoble University Hospital, Emergency Department, Grenoble

44000

RECRUITING

Nantes University Hospital, Emergency department, Nantes

47923

NOT_YET_RECRUITING

Agen-Nerac Hospital, Emergency Department, Agen

49000

RECRUITING

Angers University Hospital, Emergency department, Angers

49300

RECRUITING

Cholet Hospital, Emergency department, Cholet

63000

RECRUITING

Clermont-Ferrand University Hospital, Emergency department, Clermont-Ferrand

67000

RECRUITING

Strasbourg University Hospital, Emergency Department, Strasbourg

69000

RECRUITING

Edouard Herriot University Hospital, Emergency Department, Lyon

69495

RECRUITING

South Lyon University Hospital, Emergency department, Pierre-Bénite

72000

RECRUITING

Le Mans Hospital, Emergency department, Le Mans

75010

NOT_YET_RECRUITING

Lariboisière hospital, emergency department, Paris

75012

RECRUITING

Saint-Antoine Hospital, Emergency department, Paris

75013

NOT_YET_RECRUITING

La Pitié-Salpétrière Hospital, Emergency Department, Paris

75014

RECRUITING

Cochin Hospital, Emergency department, Paris

RECRUITING

St-Joseph Hospital, Emergency Department, Paris

75015

RECRUITING

HEGP, Emergency Department, Paris

75018

NOT_YET_RECRUITING

Bichat Hospital, Adult Emergency department, Paris

76000

NOT_YET_RECRUITING

Rouen University Hospital, Emergency Department, Rouen

79000

RECRUITING

Niort Hospital, Emergency Department, Niort

86000

RECRUITING

Poitiers University Hospital, Emergency department, Poitiers

87000

RECRUITING

Limoges University hospital, Emergency department, Limoges

91294

NOT_YET_RECRUITING

Arpajon Hospital, Emergency Department, Arpajon

95100

RECRUITING

Argenteuil hospital, Emergency department, Argenteuil

95600

RECRUITING

Simone Veil Hospital, Emergency Department, Eaubonne

06000

WITHDRAWN

Nice University Hospital, Emergency department, Nice

All Listed Sponsors
lead

University Hospital, Angers

OTHER_GOV