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 now

Conditions studied: Vitamin K-Dependent Coagulation Defect, Significant Bleeding Risk

In brief

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

Key facts

Study ID

NCT06429787

Run by

Octapharma

People needed

3574

Starts

2025-02-14

Expected to finish

2032-06-30

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Octapharma Research Site — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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