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NCT06429787
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: Vitamin K-Dependent Coagulation Defect, Significant Bleeding Risk
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 3574
Sponsor: Octapharma
Location: Octapharma Research Site Boston Massachusetts
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
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.
Source: ClinicalTrials.gov (NCT06429787). StuddyBuddy aggregates publicly available trial information.
