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
Conditions
Vitamin K-Dependent Coagulation DefectSignificant Bleeding Risk
Locations
Octapharma Research Site
Boston, Massachusetts 02215
United States