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.
Purpose
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.
Conditions
- Blood Loss, Surgical
- Coagulation Disorder
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental VMX-C001 |
Participants will be administered a fixed dose of VMX-C001 before undergoing the required procedure. |
|
|
Active Comparator Usual Pharmacological Care |
Participants will be given the usual treatment used by the site for patients receiving FXa DOACs when undergoing the required procedure. |
|
Recruiting Locations
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- VarmX B.V.