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.

  • STATUS
    Recruiting
  • days left to enroll
    44
  • participants needed
    370
  • sponsor
    Octapharma
Updated on 7 August 2021

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).

Description

The primary objective of the study is to demonstrate that the efficacy of OCTAPLEX as a reversal agent in patients under Vitami n K Antagonist (VKA)therapy with the need for urgent surgery with significant bleeding risk is clinically non-inferior to that Beriplex P/N (Kcentra).

The secondary objective of the study is to investigate the safety and tolerability of OCTAPLEX compared to Beriplex P/N (Kcentra) in patients under Vitamin K Antagonist (VKA) therapy with the need for urgent surgery with significant bleeding risk.

Details
Condition Significant Bleeding Risk
Treatment Octaplex, Beriplex P/N (Kcentra)
Clinical Study IdentifierNCT02740335
SponsorOctapharma
Last Modified on7 August 2021

Eligibility

Yes No Not Sure

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
an urgent surgery carrying significant bleeding risk (50 mL expected blood loss) is required as part of routine clinical care
the use of oral or parenteral vitamin K alone to reverse anticoagulation is deemed too slow or inappropriate for reversal
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/L 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
Patients who have received prothrombin complex concentrates (PCCs), fresh frozen plasma or vitamin K within 72 hours prior to enrollment into the study
Patients with a known history of hypersensitivity to plasma-derived products
Patients with acute major bleeding or polytrauma
Pregnant or nursing women
Patients participating in another interventional clinical study currently or during the past 30 days prior to enrollment into this study
Patients previously enrolled in this study
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