ENhanced Recovery and ABbreviated LEngth of Anticoagulation for Thromboprophylaxis After Primary Hip Arthroplasty
This study, called ENABLE-Hip, aims to find the best length of time to take blood-thinning medicine (anticoagulation) after a total hip replacement. After this surgery, there's a risk of blood clots. Currently, people often take blood thinners for about 35 days. This study wants to see if taking them for a shorter time, just 10 days, is just as effective at preventing dangerous clots like DVT (deep vein thrombosis) or PE (pulmonary embolism), and whether it could reduce the risks associated with taking medication for longer. All participants will take Rivaroxaban (Xarelto) at first, then some will switch to a dummy pill (placebo) after 10 days, while others continue the active drug. This could mean fewer days of medication for future patients if the shorter time proves safe and effective.
At a glance
What is this study about?
When you have a hip replacement, there's a chance of blood clots forming in your legs or lungs. To prevent this, doctors usually prescribe blood-thinning medication. However, there's some debate about how long people really need to take these medicines. Current practice can vary, but often involves taking them for several weeks, sometimes up to 35 days.
This study, called ENABLE-Hip, is designed to investigate if a shorter course of blood thinners – just 10 days – is as safe and effective as a longer course of 35 days. Everyone in the study will undergo a hip replacement and will be encouraged to move around early after their surgery. By comparing these two approaches, researchers hope to find out if we can reduce the number of days people need to take blood thinners, which could potentially lower side effects like bleeding, while still keeping them safe from clots.
The study will use a blood-thinning medicine called Rivaroxaban, commonly known as Xarelto. After about 10 days, some people will continue taking Rivaroxaban for a total of 35 days, while others will switch to a dummy pill, known as a placebo, for the remainder of the 35 days. This will help researchers see if there's any difference in how many people develop blood clots in each group. The main goal is to ensure that shortening the treatment doesn't lead to more clots.
Key takeaways
- This study compares 10 days vs. 35 days of blood thinners after hip replacement.
- It aims to see if a shorter treatment is just as safe for preventing blood clots.
- Participants will take Rivaroxaban (Xarelto), with some switching to a placebo later.
- The main goal is to prevent serious blood clots like DVT and PE.
- Findings could mean fewer days of medication for future patients, reducing side effects.
- Follow-up checks happen at 35 and 90 days after surgery.
Who may be eligible?
To join this study, you need to be an adult between 18 and 85 years old. You must be planning to have a single hip replacement surgery and be able to move around reasonably well before your operation. You also need to be able to understand the study information and follow the instructions, for example, being able to swallow pills.
There are also some reasons why you might not be able to take part. For instance, if you've had a known blood clot in the past, or if you've had a hip or leg fracture or major surgery within the last three months. People with certain health conditions like active cancer, a history of stomach ulcers or bleeding, severe kidney or liver problems, or a very high body weight (BMI over 40) would also not be able to participate.
If you are a woman who could become pregnant, you would need to have a negative pregnancy test and agree to use effective birth control during the study and for a short time afterwards. Men who could father a child would also need to agree to use effective birth control.
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?
- Are you having a single hip replacement surgery?
- Can you move around fairly well before your surgery?
- Do you have severe kidney or liver problems? (If yes, you likely can't join)
- Have you had a blood clot or major surgery recently? (If yes, you likely can't join)
- Can you understand directions and swallow pills easily?
What does participation involve?
If you decide to take part in this study, you'll first give your written consent. After your hip replacement surgery, you'll start taking the blood-thinning medicine, Rivaroxaban. You'll take this for about 10 days. Then, without knowing which, you will either continue with Rivaroxaban or switch to a dummy pill (placebo) for the remaining 25 days, completing a total of 35 days of daily medication. This part is 'double-blinded,' meaning neither you nor your study doctor will know whether you're taking the active drug or the dummy pill.
Throughout this time, you'll be encouraged to get up and move around after your surgery as part of an enhanced recovery plan. After you leave the hospital, you'll have follow-up visits, usually over the phone or in person, on day 35 and day 90 after your surgery. These visits are to check your health, see if you've developed any blood clots, and ensure the medication has been well-tolerated. The total duration of active follow-up for the study will be about 3 months after your surgery.
Potential risks and benefits
Locations (6)
- Kepler University Medical Center, Orthopedics and TraumatologyVerified postcodeLinz, Austria· Recruiting
- Sana Clinics Sommerfeld, Dpt. for Surgical OrthopaedicsVerified postcodeKremmen, Germany· Recruiting
- GPR Rüsselsheim Health and Care CenterVerified postcodeRüsselsheim am Main, Germany· Recruiting
- University Medical Center Mainz, Center for Orthopedics and Trauma SurgeryVerified postcodeMainz, Germany· Recruiting
- University Medical Center Dresden, University Center for Orthopaedics, Trauma & Plastic SurgeryVerified postcodeDresden, Germany· Recruiting
- Evangelical Forest Hospital Berlin - Orthopaedics and Trauma SurgeryVerified postcodeBerlin, Germany· Recruiting
Common questions
What is 'anticoagulation'?
Anticoagulation means taking medicine, often called blood thinners, to help prevent blood clots from forming.
What are DVT and PE?
DVT (deep vein thrombosis) is a blood clot in a deep vein, usually in the leg. PE (pulmonary embolism) is when a blood clot travels to the lungs, which can be very serious.
What is a 'placebo'?
A placebo is a dummy pill that looks like the real medicine but contains no active drug. It helps researchers understand the true effect of the medicine.
Will I know if I'm taking the real drug or the placebo?
No, this is a 'double-blinded' study. Neither you nor your doctor will know if you're taking the active blood thinner or the placebo after the initial 10 days.
Why is this study important?
It could help doctors find the best and safest length of time to give blood thinners after hip replacement surgery, potentially reducing medication and its side effects for many patients.
How to find out more
Nadine Martin, Dr.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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