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.
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 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.
Parallel
VMX-C001
DrugA fixed dose of VMX-C001 will be administered prior to commencement of procedure.
Usual Pharmacological Care
DrugUsual pharmacological care should be treatment planned to restore coagulation or support haemostasis for the required procedure.
Effect of VMX-C001 versus usual pharmacological care on haemostasis
Proportion of participants with good or excellent haemostatic efficacy during the required procedure.
Effect of VMX-C001 versus usual pharmacological care on FXa DOAC induced anticoagulation measured by dilute prothrombin time (dPT).
Change in dPT.
Effect of VMX-C001 versus usual pharmacological care on FXa DOAC induced anticoagulation as measured by dilute Russell Viper Venom Time (dRVVT).
Change in dRVVT.
Effect of VMX-C001 versus usual pharmacological care on the extent of actual blood loss compared to expected blood loss during procedure.
Percentage of expected blood loss.
Effect of VMX-C001 versus usual pharmacological care on bleeding severity.
Bleeding severity at the Start of procedure using a 5 point scale (grades 0 \[no bleeding\] to 4 \[life threatening\])
