A 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 requiring emergency surgery or invasive intervention.

Conditions: Perioperative prophylaxis for emergency surgery or invasive intervention in subjects who have an acquired deficiency of vitamin K-dependent coagulation factors and proteins C and S due to use of oral anticoagulation.
MedDRA version: 9.1Level: LLTClassification code 10009789Term: Coagulation factors decreased
MedDRA version: 9.1Level: LLTClassification code 10065667Term: Haemorrhage prophylaxis

Registration Number: EUCTR2007-007862-39-PL

Lead Sponsor: CSL Behring GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 176

Inclusion Criteria

- Male and female subjects = 18 years
- Subjects who have received oral inticoagulation therapy (e.g. warfarin, acenocoumarol or phenprocoumon) and in whom either an emergency surgical or an invasive intervention is indicated. Due to the nature of the procedure, withdrawal of anticoagulation therapy and plasma are also indicated,
- 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

- Subjects with emergency surgical procedures in which according to the surgeon's clinical judgment, an accurate estimate of blood loss is not possible (e.g. ruptured aneurysm),
- Administration of intravenous vitamin K more than 3 hours or administration of oral vitamin K more than 6 hours prior to infusion of study treatment,
- Expected survival of less than 3 days,
- Acute trauma for which reversal of vitamin K antagonists alone would not be expected to control an acute bleeding complication and/or control the acute bleeeding event,
- History of thrombotic event, myocardial infarction, unstable angina pectoris, cerebral vascular accident, transient ischemic attack, severe peripheral vascular disease, disseminated intravascular coagulation within 3 months of enrollment.
- Known history of antiphospholipid antibody syndrome or lupus anticoagulant antibodies,
- Suspected or confirmed sepsis at time of enrollment
- A previous thromboembolic event within 30 days prior to inclusion into the study
- Administration of whole blood, plasma, plasma fractions or platelets within 2 weeks prior to inclusion into 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 brest-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
- Modified Rankin Score > 3 prior to ICH
- 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) or have a concurrent SAH or parenchymal contusion