Clinical Trial

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
View on ClinicalTrials.gov →
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
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-05-21; most recent amendment 2026-07-15.
Status change: Not Yet Recruiting → Recruiting 2025-03-04
Trial Details
NCT Number NCT06429787
Lead Sponsor Octapharma
Conditions Vitamin K-Dependent Coagulation Defect, Significant Bleeding Risk
Enrollment 3,574 participants
Start Date 2025-02-14
Primary Completion 2031-12-31 (estimated)
Study Completion 2032-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-06