RecruitingPhase 3Drug trial
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.
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.