Study of the Prognostic Value of the Coagulolytic Balance Dependent on Circulating Microvesicles in the Occurrence of Thrombotic Events After Total Knee Replacement in Orthopedic Surgery.
This study aims to discover better ways to predict and prevent blood clots after total knee replacement surgery. Blood clots in the leg (deep vein thrombosis) or lung (pulmonary embolism) can be serious complications after this common operation. Researchers will study 387 patients undergoing their first total knee replacement across three hospitals in France. All patients will receive standard clot-preventing treatment, including a blood-thinning medicine called Lovenox® (enoxaparin) and compression stockings. The study will measure specific substances in the blood to see if they can predict who is at higher risk of developing a clot within one month after surgery. The goal is to improve how doctors assess and manage this risk, making knee replacement surgery even safer for patients.
At a glance
What is this study about?
When you have a total knee replacement, a common and very effective surgery, there's a small chance of developing blood clots afterwards. These clots can form in your legs (deep vein thrombosis, or DVT) or, less commonly, travel to your lungs (pulmonary embolism), which can be quite serious. Doctors already use blood-thinning medicines and other methods, like compression stockings, to help prevent these clots. However, scientists are always looking for even better ways to identify who might be at higher risk.
This study is designed to help us understand if certain natural substances in your blood, called 'circulating microvesicles' and related 'coagulolytic balance,' can act as early warning signs for blood clots after knee surgery. Think of them like tiny messengers in your blood that might give clues about your body's clotting system. By measuring these markers in patients undergoing knee surgery, the researchers hope to find a more accurate way to predict who might develop a clot within a month after their operation.
Over three years, 387 patients having their first total knee replacement will take part in three hospitals in France. All these patients will receive the usual care to prevent clots, which includes a daily injection of a blood thinner called Lovenox® (enoxaparin) for about 15 days, along with wearing compression stockings. The study isn't testing new treatments; instead, it's about seeing if a new way of testing blood can improve how we predict and understand the risk of clots, ultimately aiming to make recovery from knee surgery safer for everyone.
Key takeaways
- This study aims to improve blood clot prediction after knee replacement.
- It involves standard care for new knee replacement patients, plus extra blood tests.
- The goal is to find new warning signs for blood clots.
- Participation lasts about one month after surgery.
- Your contribution helps advance knowledge for future patients.
Who may be eligible?
To be considered for this study, you would need to be between 18 and 85 years old and be having your very first total knee replacement surgery for wear and tear (osteoarthritis). If you've had a knee replacement on your other knee before, there needs to be at least a 12-month gap between the two operations. Importantly, you should be generally fit for surgery, meaning your overall health, as assessed by doctors, needs to be suitable, and you shouldn't have any medical reasons that would stop you from taking the standard blood-thinning medication used in the study.
There are certain health conditions that would mean you couldn't take part. For example, if you've recently had a serious infection, cancer, or major injury in the knee joint, or if you have a weakened immune system, you wouldn't be eligible. Also, if you have severe kidney, heart, or breathing problems that might affect your body's clotting system, or if you're already taking blood thinners for another condition, this study might not be right for you. Unfortunately, the study also cannot include pregnant or breastfeeding women, or those under 18.
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 between 18 and 85 years old?
- Will this be your first total knee replacement for wear and tear?
- Are you generally fit for surgery (ASA score less than 4)?
- Can you take standard blood-thinning medication (like Lovenox®)?
- Are you able to provide informed consent and follow study procedures?
- Are you not currently pregnant or breastfeeding?
What does participation involve?
If you decide to take part, your experience will be very similar to what it would be if you weren't in the study. You will have your total knee replacement surgery as planned. After your surgery, you will receive the usual preventative treatment for blood clots: a daily injection of Lovenox® (enoxaparin) under the skin, starting 6 to 8 hours after your operation and then continuing every day for about 15 days. You will also wear compression stockings, which help with blood flow. The main difference is that researchers will take blood samples at specific times after your surgery (called D0, which means day zero, or the day of surgery) to measure the special markers they are interested in. You will then have follow-up checks, including possibly an ultrasound (echodoppler) at one month after your surgery, to look for any signs of blood clots. The total duration of your participation, including follow-up, will be about one month.
Potential risks and benefits
Locations (1)
- Assistance Publique Hopitaux de MarseilleVerified postcodeMarseille, France
Common questions
What is a 'total knee replacement'?
It's a surgery where the damaged parts of your knee joint are replaced with artificial parts, usually to relieve pain and improve movement, often due to arthritis.
What are blood clots and why are they a concern?
Blood clots are clumps of blood that can form in your veins, especially in the legs after surgery. They can be serious if they block blood flow or travel to your lungs.
What is Lovenox® (enoxaparin)?
It's a common blood-thinning medicine given by injection to help prevent blood clots from forming after surgery.
Will I get any special treatment if I join this study?
You will receive the standard, recommended care for preventing blood clots after knee surgery. The study adds extra blood tests to understand clot risk better, not different treatments.
How long will I be in the study?
Your involvement in the study, including follow-up checks, will last for about one month after your surgery.
How to find out more
Matthieu OLLIVIER
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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