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.
Completed · Phase 3
Conditions studied: Significant Bleeding Risk
In brief
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).
Key facts
- Study ID
- NCT02740335
- Run by
- Octapharma
- People needed
- 208
- Starts
- 2017-06-08
- Expected to finish
- 2022-02-23
- Last updated by the study team
- 2023-03-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
- 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.
Where it is running
- Octapharma Research Site — New Haven, Connecticut, United States
- Octapharma Research Site — Miami, Florida, United States
- Octapharma Research Site — Tampa, Florida, United States
- Octapharma Research Site — Iowa City, Iowa, United States
- Octapharma Research Site — Boston, Massachusetts, United States
- Octapharma Research Site — Rochester, New York, United States
- Octapharma Research Site — Durham, North Carolina, United States
- Octapharma Research Site — Cleveland, Ohio, United States
- Octapharma Research Site — Columbus, Ohio, United States
- Octapharma Research Site — Dayton, Ohio, United States
- Octapharma Research Site — Fairborn, Ohio, United States
- Octapharma Research Site — Pittsburgh, Pennsylvania, United States
- Octapharma Study Site — Pittsburgh, Pennsylvania, United States
- Octapharma Research Site — Pittsburgh, Pennsylvania, United States
- Octapharma Research Site — Pittsburgh, Pennsylvania, United States
- Octapharma Research Site — Pittsburgh, Pennsylvania, United States
- Octapharma Research Site (0115) — Austin, Texas, United States
- Octapharma Research Site (0127) — Austin, Texas, United States
- Octapharma Research Site — Dallas, Texas, United States
- Octapharma Research Site — Round Rock, Texas, United States
- Octapharma Research Site — Puyallup, Washington, United States
- Octapharma Research Site — Lesnoy, Belarus
- Octapharma Research Site — Minsk, Belarus
- Octapharma Research Site — Minsk, Belarus
- Octapharma Research Site — Aurora, Colorado, United States
Full record on ClinicalTrials.gov
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