Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor
This research is looking into a medication called OCTAPLEX for patients who are experiencing major bleeding while taking certain blood-thinning medicines, specifically Factor Xa inhibitors. These blood thinners are often used to prevent blood clots, but sometimes they can increase the risk of serious bleeding. The study aims to find out how well OCTAPLEX works to stop this bleeding and if it's safe to use. Patients will be randomly assigned to receive either a low dose or a high dose of OCTAPLEX. This is a large study taking place in many different hospitals, and it's designed to be very thorough in assessing the medicine's effects.
At a glance
What is this study about?
Imagine you're taking a medicine to help prevent blood clots, but suddenly, you experience a serious bleed. This study is all about finding the best way to help people in that situation. It focuses on a specific type of blood thinner called a Factor Xa inhibitor, which is commonly prescribed. The researchers are studying a medicine called OCTAPLEX, which is designed to help your blood clot normally again.
They want to carefully compare two different dose levels of OCTAPLEX – a low dose and a high dose – to see which one is more effective at stopping the bleeding and if there are any differences in side effects. This kind of research is really important because it helps doctors understand how to best treat serious bleeding events in patients who are on these crucial blood-thinning medications.
By taking part, patients could help improve future care for many others. The results of this study will provide valuable information that can help guide medical decisions and potentially make serious bleeding events safer and more manageable for people in the future.
Key takeaways
- This study is for patients on specific blood thinners (Factor Xa inhibitors) who are experiencing serious bleeding.
- It's testing two different doses of a medicine called OCTAPLEX to help stop the bleeding.
- The main goals are to see how well OCTAPLEX works and if it's safe.
- Participants will be closely monitored by medical staff.
- Understanding the risks and benefits, and giving your consent, is a key part of participating.
Who may be eligible?
To join this study, you would need to be at least 18 years old and be experiencing major bleeding. A key requirement is that you must be taking a specific type of blood-thinning medication called an oral Factor Xa inhibitor (like rivaroxaban, apixaban, or edoxaban).
The doctors will also need to check your blood to see how much of the blood thinner is still in your system, or they might consider when you last took your dose. This helps them confirm that the blood thinner is likely the cause, or a significant factor, in your bleeding.
Also, because this is a medical study, you or your legal representative would need to give your informed consent, which means agreeing in writing that you understand what the study involves and are happy to participate.
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?
- Are you currently taking a Factor Xa inhibitor blood thinner (like rivaroxaban, apixaban, or edoxaban)?
- Are you experiencing serious or major bleeding?
- Are you able to provide written consent, or can a legal representative provide it for you?
What does participation involve?
If you decide to take part, you'll be randomly assigned to receive either a low dose or a high dose of OCTAPLEX. This will be given to you as part of your treatment for the bleeding. Doctors and nurses will monitor you very closely to see how well the medicine works and to check for any side effects. You'll have regular checks, which might include blood tests, to see how your body is responding. The exact number of visits and follow-up checks will depend on your condition and the study's plan, but it's all designed to ensure your safety and gather important information. The medical team will explain everything fully before you agree to participate.
Potential risks and benefits
Locations (63)
- Harbor-UCLA Medical CenterVerified postcodeTorrance, United States· Terminated
- The University of FloridaVerified postcodeGainesville, United States· Recruiting
- St. Mary's Medical CenterVerified postcodeWest Palm Beach, United States· Recruiting
- Beth Israel Deaconess Medical CenterVerified postcodeBoston, United States· Terminated
- Hennepin County Medical CenterVerified postcodeMinneapolis, United States· Terminated
- University of Mississippi Medical CenterVerified postcodeJackson, United States· Terminated
- OU Health - University of Oklahoma Medical CenterVerified postcodeOklahoma City, United States· Terminated
- Oregon Health & Science UniversityVerified postcodePortland, United States· Terminated
- Ascension Seton Medical Center AustinVerified postcodeAustin, United States· Terminated
- Dell Seton Medical Center at the University of TexasVerified postcodeAustin, United States· Terminated
- Klinikum Klagenfurt am Wörthersee Anästhesiologie und IntensivmedizinVerified postcodeKlagenfurt, Austria· Terminated
- University Clinical Centre of the Republic of SrpskaVerified postcodeBanja Luka, Bosnia and Herzegovina· Terminated
Common questions
What kind of bleeding is considered 'major bleeding' in this study?
Major bleeding refers to serious bleeding that needs immediate medical attention, often requiring hospital treatment.
What are Factor Xa inhibitor blood thinners?
These are medicines, like rivaroxaban (Xarelto), apixaban (Eliquis), or edoxaban (Lixiana), that doctors prescribe to prevent harmful blood clots.
What is OCTAPLEX?
OCTAPLEX is a medicine that contains several 'clotting factors' – natural proteins in your blood that help it to clot. It's used to help stop bleeding.
Will I know if I'm getting the low or high dose?
No, this is a 'double-blind' study, meaning neither you nor your doctors will know which dose you're receiving. This helps make the study as fair as possible.
What does a 'Phase 3 study' mean?
A Phase 3 study means the medicine has already shown promise in earlier research, and now it's being tested on a larger group of people to confirm its effectiveness and safety before it can be widely used.
How to find out more
Sigurd Knaub, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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