Reltodecacog alfa plus usual care in adults needing urgent surgery while on a FXa DOAC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial tests whether a fixed dose of reltodecacog alfa (VMX-C001) improves hemostasis during urgent procedures in people taking FXa DOACs. Participants are randomized to receive reltodecacog alfa or the usual pharmacological reversal before surgery and are monitored with clinical assessments and labs during hospital stay, with follow-up around 28 days after the procedure. The primary outcome is the proportion of participants with good or excellent intraoperative bleeding control as judged by blinded expert assessors. Eligibility includes adults requiring urgent high-bleeding-risk surgery with a significant FXa DOAC level, and exclusion criteria limit other anticoagulants and certain risks. The study is conducted at a few Arizona centers under lead sponsor VarmX B.V.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female patient aged ≥18 years.
2. The patient or legally authorised representative (LAR) has given written informed consent.
3. The patient requires urgent surgery/procedure for which the risk of bleeding is considered high and for which haemostasis is considered necessary.
4. The patient has a significant FXa DOAC level at the time of procedure.
5. The patient would require treatment (usual pharmacological care) to restore coagulation for the required procedure.
6. The patient must be willing to use appropriate contraception.

Exclusion Criteria:

1. 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.
2. 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.
3. The patient has received any of the prespecified medications not allowed in the 7 days prior to Randomisation.
4. The patient was treated with an investigational drug \<30 days or 5 half-lives, whichever is longer, prior to Screening.
5. Expected survival, in the Investigator's judgement, is \<3 months due to comorbidity.
6. Patients in whom the Investigator considers it is not possible to estimate the expected blood loss.
7. Known "Do Not Resuscitate" order or similar advanced directive.
8. Cardiogenic shock at the time of screening unless related to the need for the required procedure.
9. The patient has sepsis (including severe sepsis or septic shock) at the time of screening.
10. The patient is pregnant or a lactating female.
11. Known hypersensitivity to any component of VMX-C001 or hamster proteins.
12. Patients who, in the opinion of the Investigator, should not participate in the study for any other reason, or inability to comply with the protocol.
13. Prior exposure to VMX-C001.

Where it's running

• Chandler Regional Medical Center (CRMC)
  Chandler, Arizona, United States Recruiting
• HonorHealth John C Lincoln Medical Center
  Phoenix, Arizona, United States Recruiting
• University of South Florida
  Tampa, Florida, United States Recruiting
• University of Iowa Health Care
  Iowa City, Iowa, United States Recruiting
• Ohio State McCampbell Outpatient Care
  Columbus, Ohio, United States Recruiting
• The University of Oklahoma Health Sciences Center
  Oklahoma City, Oklahoma, United States Recruiting

+27 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Head of Clinical Operations
• Email: m.zorer@VarmX.com
• Phone: +43 664 88375193

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.