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Recruiting 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

— Observational Vitamin K-Dependent Coagulation Defect Significant Bleeding Risk

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Balfaxar, Kcentra.
Who it may be relevant to
Registry conditions: Vitamin K-Dependent Coagulation Defect, Significant Bleeding Risk. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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.

Overview

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

Interventions

  • Drug 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
  • Drug 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

Primary outcome measures

  • TEEs within 45 days following VKA reversal treatment [Time frame: 45 days]
Secondary outcome measures (5)
  • TEEs within 7 and 14 days following VKA reversal treatment [Time frame: 14 days]
  • Median Time to TEEs [Time frame: 45 days]
  • All Cause Mortality [Time frame: 45 days]
  • Median Time to All Cause Mortality [Time frame: 45 days]
  • Rate of Fatal TEEs [Time frame: 45 days]

Eligibility criteria

Inclusion criteria

  • Subjects at least 18 years of age.
  • Subjects on VKA treatment.
  • Received 4F-PCC agent, BALFAXAR or Kcentra, for urgent reversal of within 48 hours prior to urgent surgery or invasive procedure.

Exclusion criteria

  • History of TEE within 90 days before receipt of VKA reversal therapy.
  • Subjects treated with VKA reversal therapy and not undergoing urgent invasive procedure.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Octapharma Research Site — Boston

Identifiers

NCT: NCT06429787 · LEX-212

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗