Comparing rivaroxaban and low-molecular weight heparin for preventing blood clots in patients with lower limb trauma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of rivaroxaban compared to low-molecular weight heparin (LMWH) in preventing venous thromboembolism (VTE) in patients with lower limb trauma requiring immobilization. Patients with a TRiP(cast) score of 7 or higher, indicating a high risk for VTE, will be randomly assigned to receive either rivaroxaban or LMWH for thromboprophylaxis. The study aims to determine if rivaroxaban can reduce the incidence of VTE more effectively than LMWH in this specific patient population. The trial is conducted in emergency departments across multiple hospitals.

Why it matters

Who can join: the full rules

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

Where it's running

• Angers University Hospital, Emergency department
  Angers, France Recruiting
• Argenteuil hospital, Emergency department
  Argenteuil, France Recruiting
• Cholet Hospital, Emergency department
  Cholet, France Recruiting
• Clermont-Ferrand University Hospital, Emergency department
  Clermont-Ferrand, France Recruiting
• Simone Veil Hospital, Emergency Department
  Eaubonne, France Recruiting
• Grenoble University Hospital, Emergency Department
  Grenoble, France Recruiting

Study contacts

• Study coordinator: Delphine Douillet, Doctor
• Email: Delphine.Douillet@chu-angers.fr
• Phone: 0241353637

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.