Status:
COMPLETED
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.
Lead Sponsor:
Octapharma
Conditions:
Significant Bleeding Risk
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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-...
Detailed 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 signif...
Eligibility Criteria
Inclusion
- 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/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.
Exclusion
Key Trial Info
Start Date :
June 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2022
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT02740335
Start Date
June 8 2017
End Date
February 23 2022
Last Update
March 8 2023
Active Locations (86)
Enter a location and click search to find clinical trials sorted by distance.
1
Octapharma Research Site
Aurora, Colorado, United States, 80045
2
Octapharma Research Site
New Haven, Connecticut, United States, 06510
3
Octapharma Research Site
Miami, Florida, United States, 33136
4
Octapharma Research Site
Tampa, Florida, United States, 33606