Clinical trial NCT00618098: Study of Octaplex (Human Prothrombin Complex Concentrate) and Fresh Frozen Plasma in Patients Under Vitamin K Therapy Antagonist Needing Urgent Surgery or Invasive Procedures
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Reversal of Anticoagulant Treatment
Keywords: anticoagulant reversal
urgent surgery
invasive procedures
vitamin K
prothrombin complex concentrate
Lead sponsor: Octapharma
Sponsor class: INDUSTRY
First posted: 2008-02-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: INR Response
timeFrame: 15 minutes after the end of first infusion of OCTAPLEX or FFP
measure: RBC Transfusion Units
timeFrame: Intra-operative; throughout the duration of operation
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Contact Octapharma for Facility details
state: Pennsylvania
Study officials:
affiliation: International Medical Director
name: Wolfgang Frenzel, MD
role: STUDY_DIRECTOR
References: