Actively Recruiting
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
Led by Octapharma · Updated on 2025-06-04
3574
Participants Needed
1
Research Sites
384 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects at least 18 years of age.
- Subjects on VKA treatment.
- Received 4F-PCC agent, BALFAXAR or Kcentra, for urgent reversal within 48 hours prior to urgent surgery or invasive procedure.
You will not qualify if you...
- History of thromboembolic event (TEE) within 90 days before receiving VKA reversal therapy.
- Subjects treated with VKA reversal therapy but not undergoing an urgent invasive procedure.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Octapharma Research Site
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
P
Patrick Murphy
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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