Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug aims to stop bleeding in emergency surgeries for blood thinner users

NCT ID NCT07288489

Disease control Sponsor: VarmX B.V. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether a single dose of VMX-C001 can control bleeding better than usual care in 800 patients on blood thinners who need urgent high-risk surgery. Participants receive either VMX-C001 or standard treatment before their procedure, and experts will rate bleeding control during surgery. Follow-up continues for about 28 days after the procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VMX-C001
What this could lead to
If it works, this could provide a reliable way to reverse blood thinners quickly during emergency surgeries, reducing bleeding risks.
What could go wrong
This is an early Phase 3 trial with 800 participants, so results may not apply to all patients. The treatment may not work better than usual care, and there is a risk of clotting or allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female patient aged ≥18 years. 2. The patient or legally authorised representative (LAR) has given written informed consent. 3. The patient requires urgent surgery/procedure for which the risk of bleeding is considered high and for which haemostasis is considered necessary. 4. The patient has a significant FXa DOAC level at the time of procedure. 5. The patient would require treatment (usual pharmacological care) to restore coagulation for the required procedure. 6. The patient must be willing to use appropriate contraception. Exclusion Criteria: 1. The patient is known for any reason, other than administration of a FXa DOAC, to have an increased risk of bleeding compared to a patient in a similar clinical situation. 2. The patient has received any non FXa DOAC anticoagulants within 7 days of Screening or has received heparin (UFH or LMWH) within 3 days of Screening. 3. The patient has received any of the prespecified medications not allowed in the 7 days prior to Randomisation. 4. The patient was treated with an investigational drug \<30 days or 5 half-lives, whichever is longer, prior to Screening. 5. Expected survival, in the Investigator's judgement, is \<3 months due to comorbidity. 6. Patients in whom the Investigator considers it is not possible to estimate the expected blood loss. 7. Known "Do Not Resuscitate" order or similar advanced directive. 8. Cardiogenic shock at the time of screening unless related to the need for the required procedure. 9. The patient has sepsis (including severe sepsis or septic shock) at the time of screening. 10. The patient is pregnant or a lactating female. 11. Known hypersensitivity to any component of VMX-C001 or hamster proteins. 12. Patients who, in the opinion of the Investigator, should not participate in the study for any other reason, or inability to comply with the protocol. 13. Prior exposure to VMX-C001.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Blood loss, surgical are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

blood coagulation disease Blood Loss, Surgical vascular hemostatic disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Blood loss, surgical Coagulation disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    37 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alfred Health, Melbourne

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • Aotearoa Clinical Trials - Middlemore (ACTT) Middlemore Hospital

    RECRUITING

    Papatoetoe, Auckland, 2025, New Zealand

  • Auckland City Hospital

    RECRUITING

    Grafton, Auckand, 1023, New Zealand

  • Beaumont Hospital, Royal Oak

    NOT_YET_RECRUITING

    Royal Oak, Michigan, 48073, United States

  • CHU de Saint-Etienne - Hopital Bellevue

    RECRUITING

    Saint Priest En Jarez, Pays de la Loire Region, 42270, France

  • Chandler Regional Medical Center (CRMC)

    NOT_YET_RECRUITING

    Chandler, Arizona, 85224, United States

  • Christiana Care

    NOT_YET_RECRUITING

    Newark, Delaware, 19718, United States

  • Denver Metro Orthopedics, P.C. - Englewood Location

    NOT_YET_RECRUITING

    Englewood, Colorado, 80113, United States

  • Duke University Medical Center

    NOT_YET_RECRUITING

    Durham, North Carolina, 27710, United States

  • Fiona Stanley Hospital

    NOT_YET_RECRUITING

    Murdoch, Western Australia, 6150, Australia

  • Fukuoka Neurosurgical Hospital

    RECRUITING

    Fukuoka-Shi, Fukuoka, 811-1313, Japan

  • Gloucestershire Hospitals NHS Foundation Trust - Gloucestershire Royal Hospital

    RECRUITING

    Gloucester, Gloucestershire, GL1 3NN, United Kingdom

  • Gold Coast University Hospital

    RECRUITING

    Southport, Queensland, 4215, Australia

  • Guys and St Thomas NHS Foundation Trust - St Thomas Hospital

    RECRUITING

    London, London, SE1 7EH, United Kingdom

  • HonorHealth John C Lincoln Medical Center

    RECRUITING

    Phoenix, Arizona, 85020, United States

  • Japanese Red Cross Kumamoto Hospital

    RECRUITING

    Kumamoto-shi, Kumamoto, 861-8520, Japan

  • Kings College Hospital NHS Foundation Trust

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Massachusetts General Hospital

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mater Private Hospital

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

  • Medical Center of the Rockies

    NOT_YET_RECRUITING

    Fort Collins, Colorado, 80523, United States

  • Memorial Hermann Hospital-TMC Investigational Drugs Services Pharmacy

    RECRUITING

    Houston, Texas, 77030, United States

  • Multiprofile Hospital for Active Treatment AD Haskovo

    RECRUITING

    Haskovo, 6304, Bulgaria

  • Multiprofile Hospital for Active Treatment Heart and Brain EAD

    RECRUITING

    Pleven, Pleven, 5800, Bulgaria

  • Multiprofile Hospital for Active Treatment Hristo Botev

    RECRUITING

    Vratsa, 3000, Bulgaria

  • Royal Brisbane and Women's Hospital (RBWH)

    NOT_YET_RECRUITING

    Herston, Queensland, 4006, Australia

  • St Vincent Hospital, Melbourne

    NOT_YET_RECRUITING

    Fitzroy, Victoria, 3065, Australia

  • St. Joseph's Hospital and Medical Center

    NOT_YET_RECRUITING

    Phoenix, Arizona, 85013, United States

  • Stanford Hospital and Clinics

    NOT_YET_RECRUITING

    Stanford, California, 94305, United States

  • Texas Tech University Health Sciences Center - El Paso

    NOT_YET_RECRUITING

    El Paso, Texas, 79905, United States

  • The University of Oklahoma Health Sciences Center

    NOT_YET_RECRUITING

    Oklahoma City, Oklahoma, 73126, United States

  • The University of Texas McGovern Medical School at Houston

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • UMBAL Kanev AD

    RECRUITING

    Rousse, 7002, Bulgaria

  • University of Iowa Health Care

    NOT_YET_RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33606, United States

  • Waikato Hospital

    RECRUITING

    Hamilton, Waikato Region, 3204, New Zealand

  • Wellington Hospital

    NOT_YET_RECRUITING

    Newtown, Wellington Region, 6021, New Zealand

  • William Beaumont Hospital - Troy Campus

    NOT_YET_RECRUITING

    Troy, Michigan, 48085, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.