VMX-C001 for Urgent Surgery in Patients Taking FXa DOACs

This study is testing if VMX-C001 can help control bleeding during urgent surgery or procedures for people who are taking FXa Direct Oral Anticoagulants (DOACs), which are blood thinners. Researchers want to see if VMX-C001 works better than the usual care given to help blood clot. They will compare a fixed dose of VMX-C001 to standard treatments. The main goal is to see how many participants have "good" or "excellent" control of bleeding during their procedure, as judged by experts who don't know which treatment was given. You may be able to join if you are 18 or older, need urgent surgery with a high bleeding risk, and are currently taking a FXa DOAC. The study aims to enroll 800 participants, but its current recruitment status is unclear.

Study design
This is an interventional study comparing VMX-C001 to usual care. It plans to enroll 800 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures the effect of VMX-C001 on bleeding control from the start to the end of the procedure on Day 1.

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NCT07288489

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.

Recruiting
PHASE3Ages 18+InterventionalTreatment
VarmX B.V.
~800 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:VMX-C001Usual Pharmacological Care

At a glance

Recruiting sites
19 of 37 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Effect of VMX-C001 versus usual pharmacological care on haemostasis
Measured over From start to end of required procedure (Day 1).
Blood Loss, Surgical
Coagulation Disorder
37 sites across 25 states
Arizona3
Texas3
Queensland3
Bulgaria3
Colorado2
Michigan2
Victoria2
Japan2

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  • Effect of VMX-C001 versus usual pharmacological care on haemostasisFrom start to end of required procedure (Day 1).

    Proportion of participants with good or excellent haemostatic efficacy during the required procedure.