Efficacy and Safety Study of BERIPLEX® P/N Compared With Plasma in Patients on Anticoagulant Therapy Who Require Emergency Surgery or Invasive Intervention

Original Study ID : 1474

Secondary ID : Array

NCT ID : NCT00803101

Brief Title : Efficacy and Safety Study of BERIPLEX® P/N Compared With Plasma in Patients on Anticoagulant Therapy Who Require Emergency Surgery or Invasive Intervention

Official Title : 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 Requiring Emergency Surgery or Invasive Intervention

Brief Summary :

The purpose of this study is to evaluate efficacy, safety and tolerance of Beriplex® P/N compared with plasma in regard to rapid reversal of coagulopathy induced by coumarin derivatives in subjects who require immediate correction of INR because of emergency surgery or urgent invasive intervention.

Source : CSL Behring

Overall Status : Recruiting

Start Date : October 2008

End Date : July 2011

Completion Date : July 2011

Official Title : Phase 3

Phase : Interventional

Study Design : Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Enrollment : 155

Verification Date : December 2008

First Received Date : December 4, 2008

Trial Eligibility

Criteria :
Inclusion Criteria:

- Male and female subjects ≥ 18 years,

- Subjects who have received oral anticoagulation 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.

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 bleeding 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 enrolment,

- Known history of antiphospholipid antibody syndrome or lupus anticoagulant
antibodies,

- Suspected or confirmed sepsis at time of enrolment,

- A previous thromboembolic event within 30 days prior to the 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 study medication,

- Pregnant or breast-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

Gender : Both

Minimum Age : 18 Years

Maximum Age : N/A

Healthy Volunteers : No

Facilities