Blood Loss, Surgical, Coagulation Disorder
Conditions
Keywords
Direct oral anticoagulant (DOAC), Human coagulation factor, Surgery
Brief summary
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
DRUGVMX-C001
A fixed dose of VMX-C001 will be administered prior to commencement of procedure.
DRUGUsual Pharmacological Care
Usual pharmacological care should be treatment planned to restore coagulation or support haemostasis for the required procedure.
Sponsors
VarmX B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of VMX-C001 versus usual pharmacological care on haemostasis | From start to end of required procedure (Day 1). | Proportion of participants with good or excellent haemostatic efficacy during the required procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of VMX-C001 versus usual pharmacological care on FXa DOAC induced anticoagulation measured by dilute prothrombin time (dPT). | From Pre-procedure assessment compared to baseline (Randomisation) (Day 1). | Change in dPT. |
| Effect of VMX-C001 versus usual pharmacological care on FXa DOAC induced anticoagulation as measured by dilute Russell Viper Venom Time (dRVVT). | From Pre-procedure assessment compared to baseline (Randomisation) (Day 1). | Change in dRVVT. |
| Effect of VMX-C001 versus usual pharmacological care on the extent of actual blood loss compared to expected blood loss during procedure. | From start to end of required procedure (Day 1). | Percentage of expected blood loss. |
| Effect of VMX-C001 versus usual pharmacological care on bleeding severity. | Start of procedure (Day 1). | Bleeding severity at the Start of procedure using a 5 point scale (grades 0 \[no bleeding\] to 4 \[life threatening\]) |
| Effect of VMX-C001 versus usual pharmacological care on bleeding severity prior to procedure. | Between Randomisation and Pre-procedure timepoint (Day 1). | Bleeding severity measured by blood loss. |
Countries
Australia, New Zealand, United States
Contacts
CONTACTHead of Clinical Operations
Outcome results
None listed