Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00618098
Recruitment Status : Completed
First Posted : February 18, 2008
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Octapharma

Tracking Information
First Submitted Date  ICMJE February 5, 2008
First Posted Date  ICMJE February 18, 2008
Last Update Posted Date October 18, 2016
Study Start Date  ICMJE May 2008
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00618098 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2008)
number of intra-operative red blood cell units (RBC) transfused [ Time Frame: intra-operative ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Reversal of Anticoagulant Treatment
Intervention  ICMJE
  • 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.).
  • 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
Study Arms
  • Experimental: Octaplex (human prothrombin complex concentrate)
    Participants to receive1 or more Octaplex infusions intravenously until their International Normalized Ratio (INR) was < 1.5.
    Intervention: Biological: Octaplex (human prothrombin complex concentrate)
  • Active Comparator: Fresh frozen plasma
    Participants to receive1 or more fresh frozen plasma infusions intravenously until their International Normalized Ratio (INR) was < 1.5.
    Intervention: Biological: Fresh frozen plasma
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2011)
200
Original Estimated Enrollment  ICMJE
 (submitted: February 15, 2008)
164
Actual Study Completion Date August 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00618098
Other Study ID Numbers  ICMJE LEX-205
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Octapharma
Study Sponsor  ICMJE Octapharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Wolfgang Frenzel, MD International Medical Director
PRS Account Octapharma
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP