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.
VarmX B.V.
Lead sponsor