Overview

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.

Status:
Recruiting

Trial end date:
2021-12-01

Target enrollment:

Participant gender:

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).

Phase:

Phase 3

Details

Lead Sponsor:

Octapharma

Treatments:

Protein C
Protein S
Thrombin
Vitamin K
Vitamins