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NCT06429787Recruiting

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

Octapharma

Start Date

2/14/2025

Completion Date

6/30/2032

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

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Balfaxar

DRUG

Kcentra

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Conditions

Vitamin K-Dependent Coagulation DefectSignificant Bleeding Risk

Locations

Octapharma Research Site

Boston, Massachusetts 02215

United States