Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

VMX-C001 in Patients Taking Factor Xa Inhibitors Who Need Urgent Surgery or an Invasive Procedure With High Bleeding Risk

Verified siteInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Trial treatment starts

    After you join the study, you receive VMX-C001 as a solution for infusion, which means it is given into a vein through a drip.

    The study compares VMX-C001 with usual pharmacological care, which means the standard medicine treatment normally used in this situation.

    You are in the study because you are taking a FXa DOAC, which means a factor Xa direct oral anticoagulant, a blood-thinning medicine taken by mouth.

    The trial is for an urgent surgery or another invasive procedure, which means a medical procedure that enters the body, and it is linked with a high risk of bleeding.

  2. Step 2

    Procedure period

    You undergo the required urgent surgery or invasive procedure after receiving the study treatment.

    The study checks how well your blood clotting works during the procedure.

    The main result being measured is whether your clotting control is judged to be good or excellent during the required procedure by an independent review group that does not know which treatment you received.

  3. Step 3

    Possible heparin use

    You may receive heparin if it is planned by the trial treatment approach.

    Heparin is a medicine used to help prevent blood clots.

    The trial allows treatment with or without planned administration of heparin, depending on the assigned care plan.

Who can join the trial?

10 criteria

  • 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 trial?

14 criteria

  • 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.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot yet recruitingNot recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • 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.

What is already known about the treatment

VMX-C001 - VMX-C001 is given as a solution for infusion through a vein, which means it is administered intravenously in a hospital setting by trained healthcare staff. It is an investigational medicine, so its full place in routine medical practice is still being studied in clinical trials and is not yet established in medical literature as a standard treatment. It is being evaluated for patients taking Factor Xa inhibitor blood thinners who need urgent surgery or another invasive procedure with a high risk of bleeding, where fast control of bleeding is important. At the molecular level, it is designed to help restore normal clotting by counteracting the blood-thinning effect of Factor Xa inhibitors, and it belongs to the class of reversal agents for direct oral anticoagulants.

Investigated diseases

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.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521632-12-00Protocol codeVMX-C001-06Estimated enrolment800 patientsSponsorVarmX B.V.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.