Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy

CSL Behring

Status and phase

Completed

Phase 3

Conditions

Acute Major Bleeding

Blood Coagulation Disorders

Treatments

Biological: Fresh frozen plasma

Biological: Beriplex® P/N (Kcentra)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00708435

1462 (Other Identifier)

2007-007861-19 (EudraCT Number)

BE1116_3002

Details and patient eligibility

About

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 subjects who require immediate correction of INR (International Normalized Ratio)and to stop an acute major bleeding.

Enrollment

216 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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