Study of four-factor prothrombin complex concentrate, OCTAPLEX, in patients with acute major bleeding on direct oral anticoagulant (DOAC) therapy with factor Xa inhibitor.
This study investigates a medicine called Octaplex for adult patients who are experiencing major bleeding while taking certain blood-thinning medications. These blood thinners are known as direct oral anticoagulants (DOACs), specifically those that target factor Xa. The main goal of the study is to see how well Octaplex works to stop this serious bleeding. Researchers will check if the bleeding gets better or stops completely after giving Octaplex. They will also look at how safe Octaplex is by monitoring for any side effects. This is a Phase 3 study, meaning it's a a final step before regulatory approval, to confirm the treatment works and is safe. Octaplex is given as a liquid through a drip into a vein.
At a glance
What is this study about?
This research study is looking into a medication called Octaplex. It's for adults who are taking certain blood-thinning medicines, known as direct oral anticoagulants (DOACs), and have developed serious bleeding. DOACs like these are often prescribed to prevent clots, but sometimes they can increase the risk of bleeding.
The main aim of the study is to find out how effective Octaplex is at controlling major bleeding in these specific situations. The medical team will carefully assess whether the bleeding significantly improves or stops altogether after Octaplex is given. They will describe the outcome as either 'excellent' or 'good' (meaning it worked well), or 'poor' or 'none' (meaning it didn't work well).
Additionally, the study will closely monitor several other important factors. This includes checking blood tests to see how the clotting system is responding, watching for any new blood clots forming, and looking at general health and any potential side effects over a short period after the Octaplex is given. This helps to understand both how well Octaplex works and if it's safe for patients.
Key takeaways
- The study is for adults with serious bleeding while taking certain blood thinners (DOACs).
- It tests a medicine called Octaplex, given by IV drip, to see if it stops bleeding.
- Researchers will monitor how well Octaplex works and for any side effects.
- Participants will be closely watched for 48 hours and then for 30 days.
- This is a Phase 3 study, a key step in testing new medicines.
Who may be eligible?
To join this study, you must be an adult, aged 18 years or older. There is no upper age limit, meaning older adults can also take part if they meet other criteria.
Crucially, you would need to be currently taking a specific type of blood-thinning medication called a direct oral anticoagulant (DOAC) that targets factor Xa. You would also need to be experiencing a major bleeding event at the time you might join the study.
Anyone of any sex can participate, as long as they meet the other requirements. The study doctors will carefully review your medical history to make sure the study is right for you and safe for your health.
- Am I 18 years old or older?
- Am I currently taking a blood-thinning medicine called a DOAC (like apixaban or rivaroxaban) for factor Xa?
- Am I currently experiencing major bleeding?
- Am I able to receive treatment through a drip into my vein?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you would receive Octaplex, which is a medicine given as a drip into your vein. The research team would then closely monitor your condition for a short period. This includes taking blood samples to check how the medicine is affecting your blood clotting, and regular checks of your vital signs like blood pressure and heart rate.
They will also keep a careful eye on any bleeding and whether it improves. You'd be monitored for 48 hours after receiving Octaplex to check for any side effects, and then followed up for any blood clot events or other important health changes over the next 30 days. The total duration of active follow-up for health events would be approximately one month.
Potential risks and benefits
Locations (6)
- —Croatia
- —Germany
- —Poland
- —Spain
- —Italy
- —Austria
Common questions
What kind of bleeding is considered 'major bleeding' in this study?
Major bleeding means serious bleeding that might need urgent medical attention, often because it's in a vital area or is causing a significant loss of blood.
What is a 'direct oral anticoagulant (DOAC)'?
DOACs are modern blood-thinning medicines taken by mouth, often to prevent blood clots. Some common examples include apixaban (Eliquis) or rivaroxaban (Xarelto).
What is Octaplex?
Octaplex is a medicine given into a vein (intravenously) that contains a mix of clotting factors. These factors help your blood to clot, which can stop bleeding.
Will I know if I'm getting Octaplex or something else?
This study is testing Octaplex directly, so all participants who receive the treatment will be given Octaplex. There is no placebo group in this study.
How long will I be involved in the study?
After receiving Octaplex, you would be closely monitored for 48 hours. Your health would then be followed up for any significant events over approximately 30 days.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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