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

Last updated: April 7, 2025
Sponsor: Octapharma
Overall Status: Active - Recruiting

Phase

N/A

Condition

Blood Clots

Treatment

Balfaxar

Kcentra

Clinical Study ID

NCT06429787
LEX-212
  • Ages > 18
  • All Genders

Study Summary

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 Criteria

Inclusion

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 hoursprior to urgent surgery or invasive procedure.

Exclusion

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 invasiveprocedure.

Study Design

Total Participants: 3574
Treatment Group(s): 2
Primary Treatment: Balfaxar
Phase:
Study Start date:
November 21, 2024
Estimated Completion Date:
June 30, 2032

Connect with a study center

  • Octapharma Research Site

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

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