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.

Official title

A Phase 3 Prospective Randomised Clinical Trial of VMX-C001 vs Usual Pharmacological Care in Patients Receiving a FXa Direct Oral Anticoagulant (FXa DOAC) Who Require Urgent Surgery or Other Invasive Procedure That is Associated With a High Risk of Bleeding, With or Without Planned Administration of Heparin (EQUILIBRIX-S)

Overview

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.

Interventions

• Drug VMX-C001
  A fixed dose of VMX-C001 will be administered prior to commencement of procedure.
• Drug Usual Pharmacological Care
  Usual pharmacological care should be treatment planned to restore coagulation or support haemostasis for the required procedure.

Primary outcome measures

• Effect of VMX-C001 versus usual pharmacological care on haemostasis [Time frame: From start to end of required procedure (Day 1).]

Secondary outcome measures (5)

• Effect of VMX-C001 versus usual pharmacological care on FXa DOAC induced anticoagulation measured by dilute prothrombin time (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). [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. [Time frame: From start to end of required procedure (Day 1).]
• Effect of VMX-C001 versus usual pharmacological care on bleeding severity. [Time frame: Start of procedure (Day 1).]
• Effect of VMX-C001 versus usual pharmacological care on bleeding severity prior to procedure. [Time frame: Between Randomisation and Pre-procedure timepoint (Day 1).]

Eligibility criteria

Inclusion criteria

• 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 would require treatment (usual pharmacological care) to restore coagulation for the required procedure.
• The patient must be willing to use appropriate contraception.

Exclusion criteria

• 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.
• Expected survival, in the Investigator's judgement, is <3 months due to comorbidity.
• Patients in whom the Investigator considers it is not possible to estimate the expected blood loss.
• Known "Do Not Resuscitate" order or similar advanced directive.
• Cardiogenic shock at the time of screening unless related to the need for the required procedure.
• The patient has sepsis (including severe sepsis or septic shock) at the time of screening.
• The patient is pregnant or a lactating female.
• Known hypersensitivity to any component of VMX-C001 or hamster proteins.
• 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.
• Prior exposure to VMX-C001.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 16 centers

• Chandler Regional Medical Center (CRMC) — Chandler
• St. Joseph's Hospital and Medical Center — Phoenix
• HonorHealth John C Lincoln Medical Center — Phoenix
• Stanford Hospital and Clinics — Stanford
• Denver Metro Orthopedics, P.C. - Englewood Location — Englewood
• Medical Center of the Rockies — Fort Collins
• Christiana Care — Newark
• University of South Florida — Tampa
• … and 8 more centers

Australia · 6 centers

• Royal Brisbane and Women's Hospital (RBWH) — Herston
• Mater Private Hospital — South Brisbane
• Gold Coast University Hospital — Southport
• St Vincent Hospital, Melbourne — Fitzroy
• Alfred Health, Melbourne — Melbourne
• Fiona Stanley Hospital — Murdoch

New Zealand · 4 centers

• Auckland City Hospital — Grafton
• Aotearoa Clinical Trials - Middlemore (ACTT) Middlemore Hospital — Papatoetoe
• Waikato Hospital — Hamilton
• Wellington Hospital — Newtown

Identifiers

NCT: NCT07288489 · VMX-C001-06

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗