Study of Octaplex (Human Prothrombin Complex Concentrate) and Fresh Frozen Plasma in Patients Under Vitamin K Therapy Antagonist Needing Urgent Surgery or Invasive Procedures
|Reversal of Anticoagulant Treatment||Biological: Octaplex (human prothrombin complex concentrate) Biological: Fresh frozen plasma||Phase 3|
|Study Design:||Allocation: Randomized
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|
- 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 ]
- number of intra-operative red blood cell units (RBC) transfused [ Time Frame: intra-operative ]
|Study Start Date:||May 2008|
|Study Completion Date:||August 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00618098
|United States, Pennsylvania|
|Contact Octapharma for Facility details|
|Philadelphia, Pennsylvania, United States, 19141|
|Study Director:||Wolfgang Frenzel, MD||International Medical Director|