Clareo Health | Phase 3 Trial of Reltodecacog Alfa (VMX-C001) vs Usual Pharmacological Care in Patients Taking a FXa Direct Oral Anticoagulant Who Require Urgent Surgery With or Without Heparin.
Phase 3 Trial of Reltodecacog Alfa (VMX-C001) vs Usual Pharmacological Care in Patients Taking a FXa Direct Oral Anticoagulant Who Require Urgent Surgery With or Without Heparin.
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.
You may not be if
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.
