Status:
COMPLETED
Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy
Lead Sponsor:
CSL Behring
Conditions:
Blood Coagulation Disorders
Acute Major Bleeding
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 coumarin derivatives in s...
Eligibility Criteria
Inclusion
- Male and female subjects ≥ 18 years
- Subjects who have received oral vitamin K-antagonist therapy
- Subjects who have acute major bleeding, defined as one of the following: life-threatening or potentially life-threatening, acute bleeding associated with a fall in hemoglobin (Hb) level ≥ 2g/dL, bleeding requiring blood product transfusion
- INR ≥ 2 within 3 hours before start of study treatment
- Informed consent has been obtained
Exclusion
- Expected survival of less than 3 days, or expected surgery in less than 1 day
- Acute trauma for which reversal of vitamin K antagonists alone would not be expected to control the acute bleeding event
- Use of unfractionated or low molecular weight heparin use from 24 hours prior to enrollment or expected need within 24 hours after start of infusion
- For patients with ICH: Glasgow coma score (GCS) \< 7; intracerebral hematoma volume \> 30cc as assessed by ABC/21; for subdural hematomas: maximum thickness ≥ 10 mm, midline shift ≥ 5 mm; for subarachnoid hemorrhage: any evidence of hydrocephalus; infratentorial ICH location; epidural hematomas; intraventricular extension of hemorrhage; modified Rankin score (mRS) of \>3 prior to ICH
- History of thrombotic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within 3 months of enrollment
- Known history of antiphospholipid antibody syndrome or lupus anticoagulant antibodies
- Suspected or confirmed sepsis at time of enrollment
- Administration of whole blood, plasma, plasma fractions or platelets within 2 weeks prior to inclusion into the study
- Large blood vessel rupture (e.g. in advanced cancer patient)
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT00708435
Start Date
June 1 2008
End Date
November 1 2010
Last Update
February 3 2014
Active Locations (69)
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1
Study Site
Birmingham, Alabama, United States, 35248-3280
2
Study Site
Los Angeles, California, United States, 90033
3
Study Site
San Franciso, California, United States, 94115
4
Study Site
Newark, Delaware, United States, 19718