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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT00618098
First received: February 5, 2008
Last updated: October 17, 2016
Last verified: October 2015
  Purpose
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).

Condition Intervention Phase
Reversal of Anticoagulant Treatment
Biological: Octaplex (human prothrombin complex concentrate)
Biological: Fresh frozen plasma
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Octapharma:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • number of intra-operative red blood cell units (RBC) transfused [ Time Frame: intra-operative ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: May 2008
Study Completion Date: August 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Octaplex (human prothrombin complex concentrate)
Participants to receive1 or more Octaplex infusions intravenously until their International Normalized Ratio (INR) was < 1.5.
Biological: Octaplex (human prothrombin complex concentrate)
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.).
Active Comparator: Fresh frozen plasma
Participants to receive1 or more fresh frozen plasma infusions intravenously until their International Normalized Ratio (INR) was < 1.5.
Biological: Fresh frozen plasma
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.
Other Name: 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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618098

Locations
United States, Pennsylvania
Contact Octapharma for Facility details
Philadelphia, Pennsylvania, United States, 19141
Sponsors and Collaborators
Octapharma
Investigators
Study Director: Wolfgang Frenzel, MD International Medical Director
  More Information

Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT00618098     History of Changes
Other Study ID Numbers: LEX-205 
Study First Received: February 5, 2008
Last Updated: October 17, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Octapharma:
anticoagulant reversal
urgent surgery
invasive procedures
vitamin K
prothrombin complex concentrate

Additional relevant MeSH terms:
Vitamins
Vitamin K
Thrombin
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hemostatics
Coagulants
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 06, 2016