Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcen… (NCT02740335) | Clinical Trial Compass
CompletedPhase 3
Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.
United States208 participantsStarted 2017-06-08
Plain-language summary
To demonstrate that the efficacy of OCTAPLEX as a reversal agent in patients under Vitamin K Antagonist (VKA) therapy with the need for urgent surgery with significant bleeding risk is clinically non-inferior to that Beriplex® P/N (Kcentra).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female patients at least 18 years of age.
✓. Patients currently on oral anticoagulation treatment with VKA of coumadin or warfarin type.
✓. Patients being admitted to the hospital or currently hospitalized where:
✓. Patients with an international normalized ratio (INR) of 2.0 or above at the time of decision to reverse the anticoagulation status.
✓. Patients who have given written informed consent and who are able and willing to comply with the procedures described in the study protocol.
Exclusion criteria
✕. Patients with a life expectancy of less than 48 hours per physician's judgment (e.g. patients with a Glasgow Coma Scale equal to 3 or a Head Abbreviated Injury Score of 6, patients requiring continuous inotropic or pressor support, and patients whose status is post cardiac arrest).
✕. Patients for whom the planned surgery or procedure is commonly associated with a very low bleeding risk (e.g. catheter placement, gastroscopy).
✕. Patients with a history of thromboembolic events (TEEs), myocardial infarction, unstable angina pectoris, critical aortic stenosis, cerebrovascular accident, transient ischemic attack, severe peripheral vascular disease, or disseminated intravascular coagulation within 3 months of enrollment.
✕. Patients with a known congenital bleeding disorder.
✕. Patients with a known antiphospholipid antibody syndrome.
. Patients with present or past specific factor inhibitor activity.
✕. Patients with thrombocytopenia of \<80,000/μL or history of heparin-induced thrombocytopenia.
✕. Patients who have received heparin of any type or any non-VKA anticoagulant within 24 hours prior to enrollment into the study or with potential need to receive these medications before completion of hemostasis evaluation at the end of surgery.