Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.

Phase 3

Completed

Conditions: Significant Bleeding Risk

Interventions: Drug: Beriplex P/N (Kcentra)
Drug: Octaplex

Registration Number: NCT02740335

Lead Sponsor: Octapharma

Brief Summary: To demonstrate that the efficacy of OCTAPLEX as a reversal agent in patients under Vitamin K Antagonist (VKA) therapy with the need for urgent surgery with significant bleeding risk is clinically non-inferior to that Beriplex® P/N (Kcentra).

Detailed Description: The primary objective of the study is to demonstrate that the efficacy of OCTAPLEX as a reversal agent in patients under Vitami n K Antagonist (VKA)therapy with the need for urgent surgery with significant bleeding risk is clinically non-inferior to that Beriplex® P/N (Kcentra).

The secondary objective of the study is to investigate the safety and tolerability of OCTAPLEX compared to Beriplex® P/N (Kcentra) in patients under Vitamin K Antagonist (VKA) therapy with the need for urgent surgery with significant bleeding risk.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 208

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Beriplex P/N (Kcentra)	Beriplex P/N (Kcentra)	Participants to receive1 Kcentra infusions intravenously
Octaplex	Octaplex	Participants to receive1 Octaplex infusion intravenously

Primary Outcome Measures

Name	Time	Method
Hemostatic Efficacy Rating by IEAB	At the end of the surgery	Hemostatic Efficacy rated by the Independent Endpoint Adjudication Committee based on a 1 to 4 point hemostatic efficacy scale, taking into account blood loss and transfusion requirements in the context of the surgery. Hemostatic efficacy was assessed based on objective criteria in the categories 'excellent', 'good', 'moderate', or 'none'. Ratings of 'excellent' and 'good' were considered as 'effective' hemostasis, while ratings of 'moderate' and 'none' were considered as 'ineffective' hemostasis.
Dichotomous Hemostasis Success	At the end of surgery	To demostrate clinical non-inferiority of treatment with Octaplex to treatment with Beriplex P/N (Kcentra) with respect to hemostatic success. Effective hemostatis includes Excellent and Good ratings, while Ineffective hemostasis includes Moderate, None and missing ratings from Global hemostatic efficacy observed by IEAB

Secondary Outcome Measures

Name	Time	Method
Coagulation Factor II Levels	30 minutes after the end of infusion	Change in coagulation factor levels from baseline to after the end of infusion using the Hodges-Lehmann Estimator for median differences: o Factor II The Hodges-Lehmann Estimator is a method of robust estimation. This estimator is used to give an estimate of the difference between the values in two sets of data. If the two sets of data contain m and n data points respectively, m × n pairs of points (one from each set) can be formed and each pair gives a difference of values. The Hodges-Lehmann estimator for the difference is defined as the median of the m × n differences.
Measuring of International Normalized Ratio (INR) to ≤ 1.5	30 minutes after the end of infusion	Number of patients with an international normalized ratio (INR) value of less or equal to 1.5 at 30 min (± 15 min) after the end of infusion.
Number of Patients Requiring Red Blood Cells (RBC)	At the end of surgery	Number of patients receiving red blood cells (RBC) during the surgery
Coagulation Factor X Levels	30 minutes after the end of infusion	Change in coagulation factor levels from baseline to after the end of infusion using the Hodges-Lehmann Estimator for median differences: o Factor X The Hodges-Lehmann Estimator is a method of robust estimation. This estimator is used to give an estimate of the difference between the values in two sets of data. If the two sets of data contain m and n data points respectively, m × n pairs of points (one from each set) can be formed and each pair gives a difference of values. The Hodges-Lehmann estimator for the difference is defined as the median of the m × n differences.
Coagulation Factor VII Levels	30 minutes after the end of infusion	Change in coagulation factor levels from baseline to after the end of infusion using the Hodges-Lehmann Estimator for median differences: o Factor VII The Hodges-Lehmann Estimator is a method of robust estimation. This estimator is used to give an estimate of the difference between the values in two sets of data. If the two sets of data contain m and n data points respectively, m × n pairs of points (one from each set) can be formed and each pair gives a difference of values. The Hodges-Lehmann estimator for the difference is defined as the median of the m × n differences.
Coagulation Factor IX Levels	30 minutes after the end of infusion	Change in coagulation factor levels from baseline to after the end of infusion using the Hodges-Lehmann Estimator for median differences: o Factor II Factor IX The Hodges-Lehmann Estimator is a method of robust estimation. This estimator is used to give an estimate of the difference between the values in two sets of data. If the two sets of data contain m and n data points respectively, m × n pairs of points (one from each set) can be formed and each pair gives a difference of values. The Hodges-Lehmann estimator for the difference is defined as the median of the m × n differences.

Trial Locations

Locations (8): Octapharma Research Site
🇺🇦
Zhytomyr, Ukraine
Octapharma Study Site
🇧🇬
Sofia, Bulgaria
Octapharma Research Location - Tbilisi
🇬🇪
Tbilisi, Georgia
Octapharma Research Location
🇺🇦
Dnipro, Ukraine
Regional Clinical Hospital
🇷🇺
Saratov, Russian Federation
Octapharma Research Site (0115)
🇺🇸
Austin, Texas, United States
Octapharma Research Site (0127)
🇺🇸
Austin, Texas, United States
Octapharma Research Site - Tbilisi
🇬🇪
Tbilisi, Georgia