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
NCT ID: NCT06429787
Last Updated: 2025-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
3574 participants
OBSERVATIONAL
2025-02-14
2032-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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BALFAXAR® (500 IU)
BALFAXAR will be administered by intravenous (IV) infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min). Dosing is individualized based on the patient's baseline International Normalized Ratio (INR) value and body weight
Balfaxar
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
Kcentra® (500 IU)
KCENTRA will be administered by intravenous infusion at of 0.12 mL/kg/min (\~3 units/kg/min) up to a maximum rate of 8.4 mL/min (\~210 units/min). Dosing is individualized based on the patient's baseline International Normalized Ratio (INR) value and body weight.
Kcentra
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
Interventions
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Balfaxar
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
Kcentra
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
Eligibility Criteria
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Inclusion Criteria
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
2. Subjects treated with VKA reversal therapy and not undergoing urgent invasive procedure.
18 Years
ALL
No
Sponsors
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Octapharma
INDUSTRY
Responsible Party
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Locations
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Octapharma Research Site
Boston, Massachusetts, United States
Countries
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Central Contacts
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Other Identifiers
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LEX-212
Identifier Type: -
Identifier Source: org_study_id
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