Study of Octaplex (Human Prothrombin Complex Concentrate) and Fresh Frozen Plasma in Patients Under Vitamin K Therapy Antagonist Needing Urgent Surgery or Invasive Procedures

Phase 3

Completed

Interventions: Biological: Octaplex (human prothrombin complex concentrate)
Biological: Fresh frozen plasma

Brief Summary: The purpose of this study is to determine whether Octaplex (human prothrombin complex concentrate) can reverse the effects of anticoagulants when compared to the standard treatment of fresh frozen plasma (FFP).

Detailed Description: The primary objective of the study is to demonstrate that the efficacy of Octaplex as a reversal agent in patients under vitamin K antagonist therapy with the need for urgent surgery or invasive procedures was not clinically inferior to that of FFP.

The secondary objective of the study is to investigate the safety and tolerability of Octaplex compared to FFP in patients under vitamin K antagonist therapy with the need for urgent surgery or invasive procedures.

Recruitment & Eligibility

Inclusion Criteria

Male or female patients at least 18 years of age.
Patients receiving oral anticoagulation with coumadin or warfarin derived agents.
Patients who have need for urgent surgery or an invasive procedure up to 8 hours after admission or identification of a patient currently hospitalized, where oral or parenteral vitamin K therapy is deemed too slow in its action for reversal of coumadin or warfarin anticoagulant effects.
Patients with an international normalized ratio (INR) of 2.0 or above.
Patients who have given written informed consent or for whom written informed consent has been obtained from the patient's legal representative on their behalf.
Patients able and willing to comply with the procedures laid out in the study protocol. In the case of unconscious and/or incapacitated patients, the willingness of the patient's legal representative for the patient to undergo the procedures laid out in the study protocol.

Exclusion Criteria

Patients with a life expectancy of less than 48 hours (eg, patients with a Glasgow Coma Scale (GCS) equal to 3 or a head abbreviated injury score (AIS) of 6, patients requiring continuous inotropic or pressor support, patients status post-cardiac arrest).
Patients with a history within the last 6 months of disseminated intravascular coagulation (DIC), or hyperfibrinolysis.
Patients with a known congenital coagulation disorder.
Patients with known antiphospholipid antibody syndrome or have known lupus anticoagulant antibodies.
Patients with present or past specific factor inhibitor activity.
Patients with thrombocytopenia of < 80,000 or a history of heparin induced thrombocytopenia (HIT).
Patients having received heparin of any type or any non-coumadin or warfarin anticoagulant immediately prior and/or intended to be given within the first 1 hour post-infusion.
Patients who have received vitamin K more than 3 hours prior to the infusion of study drug.
Patients with a history of hypersensitivity to plasma-derived products.
Pregnant or nursing women.
Patients participating in another clinical treatment study currently or during the past 1 month prior to study inclusion.
Patients previously enrolled in this study.

Arm && Interventions

Group	Intervention	Description
Octaplex (human prothrombin complex concentrate)	Octaplex (human prothrombin complex concentrate)	Participants to receive1 or more Octaplex infusions intravenously until their International Normalized Ratio (INR) was \< 1.5.
Fresh frozen plasma	Fresh frozen plasma	Participants to receive1 or more fresh frozen plasma infusions intravenously until their International Normalized Ratio (INR) was \< 1.5.

Primary Outcome Measures

Name	Time	Method
RBC Transfusion Units	Intra-operative; throughout the duration of operation	Total number of intra-operative units of red blood cell (RBC) given to patients
INR Response	15 minutes after the end of first infusion of OCTAPLEX or FFP	Number of patients who had an INR response, defined as the correction of patient's INR to \<1.5, 15 minutes after the end of first infusion with study medication

Secondary Outcome Measures