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
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
- DrugBalfaxar
BALFAXAR (prothrombin complex concentrate, human-lans) is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for an urgent surgery/invasive procedure
- DrugKcentra
KCENTRA, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with: * acute major bleeding or * need for an urgent surgery/invasive procedure
Location
- Octapharma Research SiteBoston, Massachusetts