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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Octapharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Reversal of Anticoagulant Treatment

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-05-01
• Primary completion: 2012-03-01
• Completion: 2012-08-01
• First posted: 2008-02-18
• Last updated: 2023-01-31
• Results posted: 2023-01-31

Locations

1 site across 1 country: United States