RIVAroxaban Versus Low-molecular Weight Heparin in Patients With Lower Limb Trauma Requiring Brace or CASTing
This study looks into two common medicines, rivaroxaban and low molecular weight heparin (LMWH), used to prevent blood clots in people who have injured their lower leg and need a cast or brace. When you can't move your leg much, there's a higher chance of developing clots, like Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE). LMWH is currently used, but this study wants to find out if rivaroxaban, which is taken as a tablet instead of an injection, is just as effective and potentially more convenient. The study focuses on people who are identified as having a higher risk of developing these clots. Researchers will compare how well both medicines work and also consider patient satisfaction and cost-effectiveness.
At a glance
What is this study about?
When you injure your leg and need it to be still in a cast or brace, your blood can flow more slowly, which increases your risk of developing blood clots. These clots, such as Deep Vein Thrombosis (DVT) in the leg or Pulmonary Embolism (PE) in the lungs, can be serious. Doctors often give medicines called 'anticoagulants' or 'blood thinners' to help prevent these clots.
Currently, a common preventative medicine is Low Molecular Weight Heparin (LMWH), which needs to be injected. While LMWH helps, some people still develop clots even when using it. Another medicine, rivaroxaban, is a tablet that you swallow. Previous research has suggested rivaroxaban might be very effective at preventing blood clots, possibly even more so than LMWH, and without increasing the risk of serious bleeding. Because it's a tablet, it could also be much easier for patients to take every day.
This study, called RIVAroxaban Versus Low-molecular Weight Heparin, wants to see if rivaroxaban is at least as good as, and perhaps even better and easier to use than, LMWH for preventing blood clots in people with lower leg injuries who are considered at higher risk of developing them. The researchers also want to find out how satisfied patients are with their treatment and if rivaroxaban is a cost-effective option for the healthcare system.
Key takeaways
- This study compares two blood clot prevention medicines: tablet rivaroxaban and injectable LMWH.
- It's for people with lower leg injuries needing a cast or brace who are at higher risk of clots.
- The goal is to see if rivaroxaban is as effective, safer, and easier to use than LMWH.
- Participation involves taking one of the medicines and attending two follow-up appointments over 3 months.
- You won't know which medicine you receive, and you can leave the study anytime.
Who may be eligible?
To join this study, you would need to be 18 years old or older and have recently visited an emergency department for a lower leg injury. This injury must require you to wear a cast or brace that will be on for at least two weeks. Importantly, doctors in the study will use a special score, called the TRiP(cast) score, to check if you have a higher risk of developing blood clots. Only those with a score of 7 or higher will be able to take part.
You cannot join the study if you need to stay in hospital for reasons other than your leg injury. Also, if you have active bleeding or a high risk of bleeding, or if you already know you can't take rivaroxaban or LMWH, you wouldn't be able to participate. If you're already taking other blood-thinning medicines (apart from a low dose of aspirin), or if you are pregnant or breastfeeding, the study won't be suitable for you.
Finally, if there's any reason that would make it difficult for you to attend follow-up appointments over a three-month period, or if you are part of another medical study that might affect this one, you wouldn't be eligible.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have a lower leg injury requiring a cast or brace for at least two weeks?
- Has a doctor told you that your risk of blood clots is high (TRiP(cast) score of 7 or more)?
- Are you able to attend follow-up appointments for about 3 months?
- Are you *not* pregnant or breastfeeding?
- Are you *not* currently taking other strong blood-thinning medicines (aspirin under 325mg/day is usually okay)?
What does participation involve?
If you join this study, you'll be randomly assigned to receive either rivaroxaban (a tablet) or LMWH (an injection). Neither you nor your doctor will get to choose which one you receive. You'll take the assigned medication for a set period while your leg is immobilised.
Researchers will follow your progress at certain times after you start the study – specifically after about 45 days and then again after 90 days. During these follow-up visits, they will check if you've developed any blood clots or experienced any bleeding. They will also ask about your satisfaction with the treatment you received. The total time you'd be involved in the study, including treatment and follow-up, would be about three months.
Potential risks and benefits
Locations (35)
- Agen-Nerac Hospital, Emergency DepartmentVerified postcodeAgen, France· Not yet recruiting
- Angers University Hospital, Emergency departmentVerified postcodeAngers, France· Recruiting
- Argenteuil hospital, Emergency departmentVerified postcodeArgenteuil, France· Recruiting
- Arpajon Hospital, Emergency DepartmentVerified postcodeArpajon, France· Not yet recruiting
- Caen University hospital, Emergency departmentVerified postcodeCaen, France· Withdrawn
- Tours University Hospital, Emergency departmentVerified postcodeChambray-lès-Tours, France· Withdrawn
- Cholet Hospital, Emergency departmentVerified postcodeCholet, France· Recruiting
- Clermont-Ferrand University Hospital, Emergency departmentVerified postcodeClermont-Ferrand, France· Recruiting
- Simone Veil Hospital, Emergency DepartmentVerified postcodeEaubonne, France· Recruiting
- Eure-Seine Hospital, Emergency DepartementVerified postcodeÉvreux, France· Recruiting
- Grenoble University Hospital, Emergency DepartmentVerified postcodeGrenoble, France· Recruiting
- La Rochelle Hospital, Adult emergency departementVerified postcodeLa Rochelle, France· Recruiting
Common questions
What is a 'blood clot' and why is it serious?
A blood clot is a clump of blood that has changed from liquid to a jelly-like or semi-solid state. In your leg, it's called Deep Vein Thrombosis (DVT), and if it travels to your lungs, it becomes a Pulmonary Embolism (PE), which can be life-threatening.
What does 'immobilisation' mean in this study?
Immobilisation means keeping your lower leg still, usually with a cast, brace, or splint, because of an injury. This helps your leg heal but can increase the risk of blood clots.
What is the TRiP(cast) score?
It's a special score doctors use to work out your individual risk of developing a blood clot after a lower leg injury. A higher score means a higher risk.
Will I know which medicine I'm getting?
No, you will be randomly assigned to either rivaroxaban or LMWH, and neither you nor the study doctors will know which one you are receiving. This is called 'blinding' and helps ensure fair results.
How long will I take the study medication?
You will take the medication for the duration that your leg needs to be in a cast or brace, as determined by your doctors, up to a maximum of approximately 45 days, with follow-up appointments extending to 90 days.
How to find out more
Delphine Douillet, Doctor
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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