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Compares treatment options for Venous Thromboembolism
Official title RIVAroxaban Versus Low-molecular Weight Heparin in Patients With Lower Limb Trauma Requiring Brace or CASTing
ClinicalTrials.gov ID: NCT06195540
What this study is testing
What is Rivaroxaban 10 MG?
Rivaroxaban 10 MG is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for venous thromboembolism.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 ;
You likely can't join if
- 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 treatment...
See the full eligibility 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.
- 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 treatment study which modifies patient care or could influence study evaluation...
The study team makes the final eligibility decision.
Where it's taking place
- Agen, France
- Angers, France
- Argenteuil, France
- Arpajon, France
- Caen, France
- Chambray-lès-Tours, France
- Cholet, France
- Clermont-Ferrand, France
- Eaubonne, France
- Évreux, France
- Grenoble, France
- La Roche-sur-Yon, France
- La Rochelle, France
- Le Mans, France
- Limoges, France
- Lyon, France
- Marseille, France
- Melun, France
- Montpellier, France
- Nancy, France
+ 11 more site(s).
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Agen, France; Angers, France; Argenteuil, France; Arpajon, France; Caen, France; Chambray-lès-Tours, France and 25 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.