Reversal of Coagulopathy

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

NCT00803101 | PHASE 3 | INTERVENTIONAL

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 subjects who require immediate correction of international normalized ratio (INR) because of emergency surgery.

30 Sites

176 Participants

Recruiting

18 Years to 55 Years

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Study Site

Newark,Delaware,United States,19718

Study site

Lexington,Kentucky,United States,40536

Study Site

Boston,Massachusetts,United States,02114

Study Site

Duluth,Minnesota,United States,55805

Study Site

Minneapolis,Minnesota,United States,55415

Study Site

Albuquerque,New Mexico,United States,87131

Study Site

Rochester,New York,United States,14642

Study Site

Winston-Salem,North Carolina,United States,27157

Study Site

Philadelphia,Pennsylvania,United States,19107

Study Site

West Reading,Pennsylvania,United States,19611

Study Site

Wilkes Barre,Pennsylvania,United States,18711

Study Site

Memphis,Tennessee,United States,38163

Study Site

Austin,Texas,United States,78701

Study site

Bryan,Texas,United States,77802

Study Site

El Paso,Texas,United States,79905

Study Site

Houston,Texas,United States,77030

Study Site

Minsk,Belarus

Study Site

Minsk,Belarus

Study Site

Rousse,Bulgaria,7002

Study Site

Sofia,Bulgaria,1606

Study Site

Varna,Bulgaria,9010

Study Site

Beirut,Lebanon,2833-7401

Study Site

Saida,Lebanon,652

Study Site

Timisoara,Romania,300736

Study Site

Barnaul,Russian Federation,656038

Study Site

Kazan,Russian Federation,420012

Study Site

Moscow,Russian Federation,105203

Study Site

Moscow,Russian Federation,125206

Study Site

Novosibirsk,Russian Federation,630051

Study Site

Saint Petersburg,Russian Federation,192242

Study Eligibility Criteria

Inclusion Criteria

* 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 Criteria

* 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

Additional Studies

Additional studies can be found at ClinicalTrials.gov