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.

Inclusion criteria

• Male or female patient aged ≥18 years.
• The patient or legally authorised representative (LAR) has given written informed consent.
• The patient requires urgent surgery/procedure for which the risk of bleeding is considered high and for which haemostasis is considered necessary.
• The patient has a significant FXa DOAC level at the time of procedure.
• The patient would require treatment (usual pharmacological care) to restore coagulation for the required procedure.
• The patient must be willing to use appropriate contraception.

Exclusion criteria

• 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.
• 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.
• The patient has received any of the prespecified medications not allowed in the 7 days prior to Randomisation.
• The patient was treated with an investigational drug <30 days or 5 half-lives, whichever is longer, prior to Screening.
• Expected survival, in the Investigator's judgement, is <3 months due to comorbidity.
• Patients in whom the Investigator considers it is not possible to estimate the expected blood loss.
• Known "Do Not Resuscitate" order or similar advanced directive.
• Cardiogenic shock at the time of screening unless related to the need for the required procedure.
• The patient has sepsis (including severe sepsis or septic shock) at the time of screening.
• The patient is pregnant or a lactating female.
• Known hypersensitivity to any component of VMX-C001 or hamster proteins.
• 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.
• Prior exposure to VMX-C001.