Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
CSL Behring
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy
