RecruitingBlood Loss, SurgicalCoagulation Disorder

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.

Eligible age

18+ yrs

Accepts

All genders

Locations

11 states

Healthy volunteers

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About this study

The goal of this clinical trial is to learn if VMX-C001 works to to allow blood clotting control in participants who take FXa Direct Oral Anticoagulants (DOACs) during surgery or other invasive procedures that carry a high risk of bleeding. The main question it aims to answer is: ● What is the proportion of participants in whom the stopping of bleeding was classed as good or excellent during the procedure, as judged by a group of experts who did not know which treatment was given? Researchers will compare a fixed dose of VMX-C001 to the usual treatment that would be given for the required procedure. Participants will: * Be given either a fixed dose of VMX-C001 or usual treatment before they undergo the required procedure in theatre * Have regular clinical assessments, including laboratory tests, during their hospital stay following the procedure * Return to the clinic for a check-up and tests approximately 28 days after the procedure was conducted.

Sponsor: VarmX B.V.

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.