Phase 3 Trial of VMX-C001 vs Usual Pharmacological Care in Patients Taking a FXa Direct Oral Anticoagulant Who Require Urgent Surgery With or Without Heparin.
This research study is for people who are taking certain blood-thinning medicines (called FXa DOACs) and need urgent surgery or a similar procedure where there's a high risk of bleeding. Blood thinners usually make it harder for blood to clot, which can be a problem during surgery. The study is testing a new medicine called VMX-C001 to see if it helps control bleeding better than the standard care. We want to find out how many patients receiving VMX-C001 have good or excellent bleeding control during their procedure, compared to those receiving usual treatment. Participants will receive either VMX-C001 or usual care, have hospital assessments, and a follow-up visit about a month later.
At a glance
What is this study about?
When you need surgery or another medical procedure, it’s important that your blood can clot properly to stop too much bleeding. However, many people take blood-thinning medicines, also known as anticoagulants (specifically, FXa DOACs), to prevent harmful blood clots. These medicines are very important, but they can make it more challenging to control bleeding if you need urgent surgery.
This study is looking at a new medicine called VMX-C001. We want to see if VMX-C001 can help blood clot normally during urgent operations or procedures for people who are currently taking these specific blood-thinning medicines. The main aim is to find out if VMX-C001 is better than the usual care given to control bleeding during these situations. A team of experts will check how well bleeding is stopped during each procedure without knowing which treatment the patient received.
By taking part, you would be helping doctors understand if VMX-C001 could be a new and effective way to manage bleeding for patients on blood thinners needing urgent procedures. This could potentially improve safety for many people in the future.
Key takeaways
- The study tests a new medicine (VMX-C001) to help control bleeding during urgent surgery.
- It's for people taking specific blood-thinning medicines (FXa DOACs).
- You'll either receive VMX-C001 or standard care, and won't know which one.
- Your health will be monitored closely in hospital and during a follow-up visit a month later.
- Participation is voluntary, and you can withdraw at any time.
- This research helps doctors find better ways to manage bleeding risks during surgery.
Who may be eligible?
You might be able to join this study if you are 18 years or older, need urgent surgery or a high-risk procedure, and are currently taking a specific type of blood-thinning medicine called a FXa DOAC. The doctors must believe you need treatment to help your blood clot for your upcoming procedure.
However, you won't be able to join if you have other medical conditions that significantly increase your risk of bleeding, or if you've recently taken other types of blood thinners or experimental drugs. You also can't take part if you are pregnant or breastfeeding, have a severe infection, or a very short life expectancy for other health reasons. If you have a known allergy to VMX-C001 or hamster proteins, you also wouldn't be able to join.
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.
- Am I 18 years old or older?
- Am I currently taking a FXa DOAC blood thinner?
- Do I need urgent surgery or a high-risk procedure where bleeding control is important?
- Am I willing to come back for a check-up about a month after my procedure?
- Am I not pregnant or breastfeeding?
- Do I not have a known allergy to VMX-C001 or hamster proteins?
What does participation involve?
If you decide to take part, you will be randomly assigned to receive either the new medicine, VMX-C001, or the usual treatment that would normally be given to help blood clot during your urgent surgery. This will happen just before your procedure in the operating theatre.
After your procedure, doctors and nurses will check on you regularly while you are in hospital. This will include keeping an eye on your general health and taking blood samples for lab tests. After you leave the hospital, you'll need to come back for one final check-up appointment. This follow-up visit will be about 28 days (roughly one month) after your surgery to see how you're doing and to take some more blood tests. The total time you'd be involved in the study would be from just before your surgery until that 28-day check-up.
Potential risks and benefits
Locations (37)
- Chandler Regional Medical Center (CRMC)Verified postcodeChandler, United States· Not yet recruiting
- St. Joseph's Hospital and Medical CenterVerified postcodePhoenix, United States· Not yet recruiting
- HonorHealth John C Lincoln Medical CenterVerified postcodePhoenix, United States· Recruiting
- Stanford Hospital and ClinicsVerified postcodeStanford, United States· Not yet recruiting
- Denver Metro Orthopedics, P.C. - Englewood LocationVerified postcodeEnglewood, United States· Not yet recruiting
- Medical Center of the RockiesVerified postcodeFort Collins, United States· Not yet recruiting
- Christiana CareVerified postcodeNewark, United States· Not yet recruiting
- University of South FloridaVerified postcodeTampa, United States· Recruiting
- University of Iowa Health CareVerified postcodeIowa City, United States· Not yet recruiting
- Massachusetts General HospitalVerified postcodeBoston, United States· Not yet recruiting
- Beaumont Hospital, Royal OakVerified postcodeRoyal Oak, United States· Not yet recruiting
- William Beaumont Hospital - Troy CampusVerified postcodeTroy, United States· Not yet recruiting
Common questions
What are FXa DOACs?
FXa DOACs are a type of blood-thinning medicine that stops blood from clotting. Examples include apixaban (Eliquis), rivaroxaban (Xarelto), and edoxaban (Lixiana).
Will I know if I'm getting VMX-C001 or usual care?
No, you won't know which treatment you receive. This is called a 'blinded' study, which helps make sure the results are fair and unbiased.
What does 'urgent surgery' mean in this study?
It means you need an operation or procedure relatively quickly, where there's a high risk of bleeding, and your doctors believe your blood needs help clotting.
What kind of tests will I have?
You'll have regular physical checks and blood tests during your hospital stay and at your final follow-up visit about a month after your procedure.
How long will my involvement in the study last?
Your involvement will be from just before your surgery until your final follow-up visit, which is about 28 days later.
How to find out more
Head of Clinical Operations
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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