An open-label, randomized, multicenter Phase IIIb study to assess the efficacy, safety and tolerance of BERIPLEX® P/N compared with plasma for rapid reversal of coagulopathy induced by coumarin derivatives in subjects with acute major bleeding.

• Conditions: This study looks into the therapy of major bleeding resulting from an acquired deficiency of vitamin K-dependant coagulation factors and proteins C and S due to use of oral anticoagulation therapy.; MedDRA version: 9.1Level: LLTClassification code 10009789Term: Coagulation factors decreased; MedDRA version: 9.1Level: LLTClassification code 10005103Term: Bleeding

• Registration Number: EUCTR2007-007861-19-PL
• Lead Sponsor: CSL Behring GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

•Male and female subjects = 18 years,
•Subjects who have received anticoagulation therapy (warfarin, acenocoumarol or phenprocoumon),
•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 Hb level = 2g/dL,
-Bleeding requiring blood product transfusion (blood products include plasma, red blood cells and other coagulation factor products),
•INR = 2 within 3 hours before start of study treatment,
•Informed consent has been obtained.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Expected survival o f 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,
•For patients with ICH:
-Glasgow coma score <9,
-Intracerebral hematoma volume > 30 cc as assessed by ABC/2¹,
-For subdural hematomas: maximum thickness = 10mm, midline shift = 5mm,
-For subarachnoid hemorrhage: any evidence of hydrocephalus,
-Infratentorial ICH location,
-Epidural hematomas,
-Intraventricular extension of hemorrhage,
-Modified Rankin score 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 enrolment,
•Known history of antiphospholipid antibody syndrome or lupus anticoagulant antibodies,
•Suspected or confirmed sepsis at time of enrolment,
•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,
-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.
*Subjects with acute major bleeding requiring minimal invasive procedures (e.g. endoscopy, bronchoscopy, central lines) that are indicated for diagnostic or therapeutic reasons are not excluded per protocol, as long as plasma is intended to be given for treatment of major bleeding.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified