A Phase 3 interventional study of VMX-C001 and Usual Pharmacological Care in Blood Loss, Surgical and Coagulation Disorder, sponsored by VarmX B.V.. Recruiting at 37 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by VarmX B.V. · Phase 3, Interventional, and Treatment
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:
Exclusion Criteria:
Participants will be administered a fixed dose of VMX-C001 before undergoing the required procedure.
Drug: VMX-C001
Participants will be given the usual treatment used by the site for patients receiving FXa DOACs when undergoing the required procedure.
Drug: Usual Pharmacological Care
A fixed dose of VMX-C001 will be administered prior to commencement of procedure.
Usual 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.
Time frame: From start to end of required procedure (Day 1).
Effect of VMX-C001 versus usual pharmacological care on FXa DOAC induced anticoagulation measured by dilute prothrombin time (dPT).
Change in dPT.
Time frame: From Pre-procedure assessment compared to baseline (Randomisation) (Day 1).
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.
Time frame: From Pre-procedure assessment compared to baseline (Randomisation) (Day 1).
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.
Time frame: From start to end of required procedure (Day 1).
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 \[life threatening\])
Time frame: Start of procedure (Day 1).
Effect of VMX-C001 versus usual pharmacological care on bleeding severity prior to procedure.
Bleeding severity measured by blood loss.
Time frame: Between Randomisation and Pre-procedure timepoint (Day 1).
Plan to share: Yes — VarmX will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external, verified, qualified scientific and medical researchers. Information on the process and requirements for submitting a voluntary data sharing request for IPD can be obtained from info@varmx.com
Supporting information: Study protocol
No publications or documents are linked to this record.
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