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RIVACAST - RIVAroxaban versus low-molecular weight heparin in patients with lower limb trauma requiring brace or CASTing
EU CTIS ID: 2023-509905-62-00
What this study is testing
The main objective is to demonstrate the non-inferiority of Rivaroxaban versus LMWH in the primary prevention of symptomatic thromboembolic events in patients with orthopaedic immobilisation for lower limb trauma and considered as high-risk of VTE according to TRiP(cast) score (≥ 7)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Consultation in one of the Emergency Departments of the participating centres
- Lower limb injury requiring rigid or semi-rigid orthopaedic immobilisation
- Intended duration of orthopaedic immobilisation of 2 weeks or more
- TRiP(cast) score ≥ 7
- Full insurance cover
You likely can't join if
- Active bleeding or high risk of bleeding
- Contra-indication to Rivaroxaban or LMWH
- Any anticoagulant or antiplatelet treatment prior to trauma (only antiaggregant treatment authorized: aspirin < 325mg/day)
- Pregnant or breastfeeding woman
- Factors rendering 3-month follow-up impossible
- Participation in any interventional study which modifies patient care or could influence study evaluation criteria
See the full eligibility criteria
- Age ≥ 18 years
- Consultation in one of the Emergency Departments of the participating centres
- Lower limb injury requiring rigid or semi-rigid orthopaedic immobilisation
- Intended duration of orthopaedic immobilisation of 2 weeks or more
- TRiP(cast) score ≥ 7
- Full insurance cover
- Signed and dated free informed consent
- Active bleeding or high risk of bleeding
- Contra-indication to Rivaroxaban or LMWH
- Any anticoagulant or antiplatelet treatment prior to trauma (only antiaggregant treatment authorized: aspirin < 325mg/day)
- Pregnant or breastfeeding woman
- Factors rendering 3-month follow-up impossible
- Participation in any interventional study which modifies patient care or could influence study evaluation criteria
- Patient requiring hospitalization following emergency for a reason other than lower limb trauma
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.