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Post Marketing Observational Study on Safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure

Post Marketing Observational Study on Safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure

Recruiting
18 years and older
All
Phase N/A
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Overview

Post marketing observational study on safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure

Eligibility

Inclusion Criteria:

  1. Subjects at least 18 years of age.
  2. Subjects on VKA treatment.
  3. Received 4F-PCC agent, BALFAXAR or Kcentra, for urgent reversal of within 48 hours prior to urgent surgery or invasive procedure.

Exclusion Criteria:

  1. History of TEE within 90 days before receipt of VKA reversal therapy.
  2. Subjects treated with VKA reversal therapy and not undergoing urgent invasive procedure.

Study details
    Vitamin K-Dependent Coagulation Defect
    Significant Bleeding Risk

NCT06429787

Octapharma

15 May 2026

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