Official Title: “A Randomized, Open Label, Efficacy and Safety Study of OCTAPLEX and Fresh Frozen Plasma (FFP) in Patients Under Vitamin k Antagonist Therapy With the Need for Urgent Surgery or Invasive Procedures”

The purpose of this study is to determine whether Octaplex works at reversing the effects of the anticoagulants when compared to the standard treatment of receiving fresh frozen plasma (FFP).

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment

Study Primary Completion Date: September 2009

The primary objective of the study is to demonstrate the efficacy of OCTAPLEX as a reversal agent in patients under vitamin K antagonist therapy with the need for urgent surgery or invasive procedures is 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

Intervention(s) in this Clinical Trial

• Drug: prothrombin complex concentrate
  • The OCTAPLEX dose will depend on the weight and baseline INR of the patient and will be calculated by the responsible treating investigator based on the dosing formula and the pre-defined INR to a value of <1.5.
• Biological: Fresh Frozen Plasma
  • The dose of FFP will depend on the weight and baseline INR of the patient. FFP will be given as a continuous intravenous infusion. The dosage should be 10 mL/kg for a patient that has an initial INR of <3 and 15 mL/kg for a patient that has an initial INR of >3. This will be given over 90 minutes or as fast as clinically indicated or tolerated by the patient at the discretion of the investigator (each unit of FFP contains roughly 200 mL).

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• There will be two primary end points in this study. The first primary efficacy endpoint is the correction of INR to < 1.5.
  • Time Frame: 15 minutes after the end of first infusion of OCTAPLEX or FFP
    Safety Issue?: Yes

Secondary Measures

• number of intra-operative red blood cell units (RBC) transfused
  • Time Frame: intra-operative
    Safety Issue?: Yes

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 (e.g. Patients with a GCS
• [Glasgow Coma Scale] equal to 3 or a head AIS [abbreviated injury score] of 6, patients requiring continuous inotropic or pressor support, patients status post cardiac arrest) (Appendix 7).
• 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 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 hr 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 and 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Octapharma

Overall Clinical Trial Officials and Contacts

Wolfgang Frenzel, MD Study Director International Medical Director  

Overall Contact: Robin Scully, R.N., M.B.A 201-604-1124 robin.scully@octapharma.com

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00618098

Study ID Number: LEX-205

ClinicalTrials.gov Identifier: NCT00618098

Health Authority: United States: Food and Drug Administration