Status:
COMPLETED
An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure
Lead Sponsor:
CSL Behring
Conditions:
Reversal of Coagulopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate efficacy, safety and tolerance of Beriplex® P/N (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by vitamin K antagonists in ...
Eligibility Criteria
Inclusion
- Male and female subjects greater than or equal to 18 years,
- Subjects currently on oral vitamin K antagonist (VKA) therapy,
- An urgent surgical procedure is required within 24 hours of the start of investigational medicinal product (IMP),
- Due to the nature of the procedure, withdrawal of oral VKA therapy and infusion of plasma are also indicated to reverse the VKA effect,
- INR greater than or equal to 2 within 3 hours before start of IMP,
- Informed consent has been obtained.
Exclusion
- Subjects requiring urgent surgical procedures where according to the surgeon's clinical judgment, an accurate estimate of blood loss is not possible (e.g., ruptured aneurysm),
- Subjects for whom administration of intravenous vitamin K and vitamin K antagonists withdrawal alone can adequately correct the subject's coagulopathy before initiation of the urgent surgical procedure,
- Administration of intravenous vitamin K more than 3 hours or administration of oral vitamin K more than 6 hours prior to infusion of IMP,
- Subjects in whom lowering INR within normal range may present an unacceptable risk for a thromboembolic complication where the INR goal is to lower but not normalize the INR because of risk of a procedure-associated stroke,
- Subjects, who despite medical management that includes close monitoring and diuretics, may not, by investigator assessment, tolerate the total volume of IMP required by the protocol,
- Expected need for additional non-study blood products before infusion of IMP (Note: Administration of packed red blood cells is not an exclusion criterion),
- Expected need for platelet transfusions or desmopressin before Day 10,
- Acute trauma for which reversal of vitamin K antagonists alone would not be expected to control or resolve an acute bleeding complication and/or control the acute bleeding event,
- Unfractionated or low molecular weight heparin use within 24 hours before randomization or potential need before completion of the procedure,
- History of thromboembolic event, myocardial infarction, unstable angina pectoris, critical aortic stenosis, cerebral vascular accident, transient ischemic attack, severe peripheral vascular disease, disseminated intravascular coagulation within 3 months of enrollment,
- Reversal of VKA therapy alone may not resolve the coagulopathy (eg, receiving a potent anti-platelet agent, i.e., clopidogrel or prasugrel, or advanced liver disease),
- Known history of antiphospholipid antibody syndrome or lupus anticoagulant antibodies,
- Suspected or confirmed serious viral or bacterial infection, e.g., meningitis, or sepsis at time of enrollment,
- Administration of whole blood, plasma, plasma fractions or platelets within 2 weeks prior to inclusion into the study (Note: Administration of packed red blood cells is not an exclusion criterion),
- Pre-existing progressive fatal disease with a life expectancy of less than 2 months,
- Known inhibitors to coagulation factors II, VII, IX, or X; or hereditary protein C or protein S deficiency; or heparin-induced, type II thrombocytopenia,
- Treatment with any other investigational medicinal product within 30 days prior to inclusion into the study,
- Presence or history of hypersensitivity to components of the study medication,
- Pregnant or breast-feeding women,
- Prior inclusion in this study or any other CSL Behring sponsored Beriplex study,
- For subjects with intracranial hemorrhage with:
- Glasgow Coma Score \<10 (see Appendix 8)
- Modified Rankin Score \> 3 prior to ICH (see Appendix 9)
- Intracerebral hemorrhage
- Epidural hematomas
- Infratentorial hemorrhage
- Subarachnoid hemorrhage (SAH) subjects with a Hunt and Hess Scale \>2
- Subdural hematomas that:
- are judged to be an acute subdural hematoma (based on neurosurgeon review)
- have a concurrent SAH or parenchymal contusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT00803101
Start Date
February 1 2009
End Date
February 1 2013
Last Update
April 6 2015
Active Locations (30)
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1
Study Site
Newark, Delaware, United States, 19718
2
Study site
Lexington, Kentucky, United States, 40536
3
Study Site
Boston, Massachusetts, United States, 02114
4
Study Site
Duluth, Minnesota, United States, 55805