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NCT Number: 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

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

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Key information

Conditions

Vitamin K-Dependent Coagulation Defect Significant Bleeding Risk Vitamin K-Dependent Clotting Factors, Combined Deficiency Of, 1

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Octapharma Research Site

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Balfaxar

Drug

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

Drug

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 outcomes

  1. TEEs within 45 days following VKA reversal treatment

    Time frame: 45 days

    Proportion of subjects diagnosed with TEEs within 45 days following VKA reversal treatment with BALFAXAR compared to proportion of subjects diagnosed with TEEs within the same period following VKA reversal treatment with Kcentra.

Secondary outcomes

  1. TEEs within 7 and 14 days following VKA reversal treatment

    Time frame: 14 days

    Proportion of subjects diagnosed with TEEs within 7 and 14 days following VKA reversal treatment with BALFAXAR compared to proportion of subjects diagnosed with TEEs within the same period following VKA reversal treatment with Kcentra.

  2. Median Time to TEEs

    Time frame: 45 days

    Median time to TEE following administration of BALFAXAR compared to median time to TEE following administration of Kcentra

  3. All Cause Mortality

    Time frame: 45 days

    Proportion of subjects who die from any reason within 7, 14 and 45 days following VKA reversal treatment with BALFAXAR compared to proportion of subjects who die from any reason within the same time period following treatment with Kcentra.

  4. Median Time to All Cause Mortality

    Time frame: 45 days

    Median time to death following administration of BALFAXAR compared to median time to death following administration of Kcentra

  5. Rate of Fatal TEEs

    Time frame: 45 days

    Rate of fatal TEEs following treatment with BALFAXAR compared to rate of fatal TEEs following treatment with Kcentra within 7, 14 and 45 days following VKA reversal treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Patrick Murphy

CONTACT

[email protected]

8663371868

Sponsors and collaborators

Lead sponsor

Octapharma

Industry

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2031
Study completion
2032
First posted
May 28, 2024
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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