This clinical trial is studying people who are taking a Factor Xa inhibitor, a blood thinner that helps prevent harmful blood clots, and who need urgent surgery or another invasive procedure, meaning a medical procedure that enters the body and has a high risk of bleeding. The study is testing VMX-C001, an intravenous medicine given through a vein, compared with usual medical care. The purpose of the study is to see how well VMX-C001 helps control bleeding during the urgent procedure.
People in the study will receive either VMX-C001 or the usual care used for this situation. Some participants may also receive heparin, another blood-thinning medicine, if planned by the treating team. The study is designed to compare the two approaches during the procedure and shortly afterward, without changing the urgent care needed for the surgery or procedure.
Who Can Join the Study?
The person must be an adult, meaning 18 years of age or older.
The person must weigh at least 40 kg (about 88 pounds).
The person, or a legally authorized representative if the person cannot give consent, must have signed written informed consent, which means written permission to take part after the study has been explained.
The person must need urgent surgery or another urgent invasive procedure, meaning a medical procedure that enters the body and cannot be delayed.
The urgent procedure must have a high risk of bleeding, and control of bleeding must be needed during the procedure.
The person must have a significant FXa DOAC level at the time of the procedure, meaning there is still a meaningful amount of a Factor Xa direct oral anticoagulant in the blood. A Factor Xa direct oral anticoagulant is a blood thinner medicine that helps prevent clots.
The usual medicine care for the urgent surgery or procedure must be one of the study’s preselected medicines, meaning one of the specific medicines already planned for use in the study.
If the person is male, he must agree to use effective contraception, such as a condom, and must not donate sperm until 90 days after receiving the study medicine.
If the person is a woman who could become pregnant, she must have a negative pregnancy test at screening, meaning the test must show she is not pregnant before joining.
If the person is a woman who could become pregnant, she must agree to use highly effective contraception from screening until 28 days after receiving the study treatment.
Who Cannot Join the Study?
The patient has a higher risk of bleeding for any reason other than taking a Factor Xa inhibitor medicine.
The patient is pregnant or is breastfeeding (lactating female means a woman who is producing breast milk).
The patient has a known allergy or strong reaction to any part of VMX-C001 or to hamster proteins (proteins from hamsters used in making the medicine).
The patient has had VMX-C001 before.
The patient has taken any non-FXa DOAC anticoagulant within 7 days before screening. An anticoagulant is a medicine that helps prevent blood clots.
The patient has received heparin (either UFH, which means unfractionated heparin, or LMWH, which means low molecular weight heparin) within 3 days before screening.
The patient has used any of the not-allowed medicines within 7 days before randomisation. Randomisation means being placed into a study group by chance.
The patient took an investigational drug within 30 days before screening, or within 5 drug half-lives, whichever is longer. An investigational drug is a medicine being studied and not yet approved for general use.
The investigator thinks the patient is unlikely to survive for 3 months because of another serious medical condition, not counting the risk from the urgent surgery or procedure itself.
The investigator cannot estimate how much blood the patient may lose, such as in a patient with polytrauma (multiple serious injuries).
The patient has a Do Not Resuscitate order or a similar advance directive. This means instructions not to use emergency measures to restart breathing or the heart.
The patient has cardiogenic shock at screening, unless it is caused by the need for the required procedure. Cardiogenic shock means the heart is not pumping enough blood to the body.
The patient has sepsis, including severe sepsis or septic shock, at screening. Sepsis is a serious body reaction to infection.
The investigator believes the patient should not take part for any other reason, or the patient cannot follow the study requirements.
VMX-C001 is the study medicine being tested in this trial. It is given through a vein as an infusion. The trial is looking at whether it can help control bleeding and support normal blood clotting in people who need urgent surgery or another invasive procedure while taking a factor Xa direct oral anticoagulant. In simple terms, it is meant to help the body manage bleeding risk during the procedure.
Usual pharmacological care is the standard medical treatment used in the control group. This means the doctors give the regular medicines or care they would normally use in this situation instead of the study medicine. The trial compares this standard approach with VMX-C001 to see which one works better for controlling bleeding during urgent surgery or procedures.
Patients receiving Factor Xa inhibitor therapy who require urgent high-bleeding-risk intervention – This refers to people who are taking a Factor Xa inhibitor, a medicine that reduces blood clotting, and then need an urgent surgery or invasive procedure that carries a high chance of bleeding. The condition is not a single disease, but a clinical situation where normal clotting is reduced by the medicine. It progresses by maintaining a lowered ability of the blood to clot, which can make bleeding more likely during the procedure. The main concern is that the effect of the inhibitor may still be present when the intervention must be done.
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