Study of Octaplex (Human Prothrombin Complex Concentrate) and Fresh Frozen Plasma in Patients Under Vitamin K Therapy Antagonist Needing Urgent Surgery or Invasive Procedures
Condition: Reversal of Anticoagulant Treatment
Intervention: Octaplex (human prothrombin complex concentrate); Fresh frozen plasma
Intervention description: INR is determined 15 minutes after the end of each infusion. Each dose (mL/kg body weight) was calculated as = ln(INR/1.4)/0.52. The maximum dose for initial treatment was not to exceed 5500 IU. If the INR is ≥ 1.5 after the initial infusion, additional infusions will be repeated until the INR was < 1.5. Octaplex (500 units, IU) is supplied in vials and was reconstituted with 20 mL of Water for Injection (Ph.Eur.).; INR is determined 15 minutes after the end of each infusion. The initial dose is 10 mL/kg for a participant with an initial INR of < 3 and 15 mL/kg for a participant with an initial INR of ≥ 3. If the INR is ≥ 1.5 after the initial infusion, additional infusions of 5 mL/kg will be repeated until the INR was < 1.5. Fresh frozen plasma is supplied by the blood bank at each study site and will be prepared and handled according to the site's standard practice.
Intervention MeSH terms: Thrombin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: anticoagulant reversal; urgent surgery; invasive procedures; vitamin K; prothrombin complex concentrate

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).
    

Eligibility criteria:

        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.