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Completed

NCT Number: NCT02319460

An Observational Cohort Study to Investigate the Risk of Thromboembolic Events in Patients Receiving Kcentra® or Plasma to Reverse Vitamin K Antagonist (VKA) Therapy in the Setting of Acute Major Bleeding

This observational cohort study is designed to obtain product safety information from the routine clinical setting within large, diverse, community-based populations. In the setting of acute major bleeding in which patients are treated for Vitamin K antagonist reversal, the risk of thromboembolic events (TEE) in patients treated with Kcentra® and in patients treated with plasma will be assessed.

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Key information

Conditions

Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Study Site

Oakland, California, 94612, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18 years and older at admission for VKA-associated major bleeding
  • A minimum of 365 days of continuous health plan enrollment before the index hospitalization involving acute VKA reversal treatment
  • A minimum of 365 days of continuous pharmacy benefit before the index hospitalization involving acute VKA reversal treatment

Exclusion criteria

Patients will be excluded from the primary analyses if they:

  • Require urgent reversal of VKA therapy in the setting of bleeding due to major trauma (eg, motor vehicle accident)
  • Requiring urgent reversal of VKA therapy for a surgical procedure unrelated to major bleeding (eg, appendicitis)

Treatment and study plan

Kcentra®

Biological

Kcentra®, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product that contains coagulation Factors II, VII, IX and X, and antithrombotic Proteins C and S as a lyophilized concentrate.

Other names: Prothrombin Complex Concentrate (Human), Beriplex

plasma

Biological

Primary outcomes

  1. Risk of thromboembolic events (TEE) for patients without a recent history of TEE

    Time frame: Within 45 days after the index date

    The risk of confirmed thromboembolic events (TEE) will be estimated for patients without a recent history of TEE treated with Kcentra® compared to patients treated with plasma. The index date is the date of acute VKA reversal for major bleeding event.

Secondary outcomes

  1. Risk of thromboembolic events

    Time frame: Within 45 days after the index date

    The risk of confirmed TEE and confirmed fatal TEE will be each estimated for patients treated with Kcentra® compared to patients treated with plasma, overall and for patients in the following subgroups:

    • Recent history of TEE
    • No recent history of TEE
    • Any history of TEE

    The index date is the date of acute VKA reversal for major bleeding event.

  2. Risk of death from any cause

    Time frame: Within 45 days after the index date

    The risk of death from any cause will be estimated for patients treated with Kcentra® compared to patients treated with plasma, overall and for patients in the following subgroups:

    • Recent history of TEE
    • No recent history of TEE
    • Any history of TEE

    The index date is the date of acute VKA reversal for major bleeding event.

  3. Rates of use of VKA therapy after the index date

    Time frame: Within 90 days after the index date

    The rates of use of VKA therapy or other antithrombotic agents will be assessed among patients with and without any history of TEE. The index date is the date of acute VKA reversal for major bleeding event.

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Collaborators

  • Kaiser Permanente

Registry information

Official study title

An Observational Cohort Study of the Risk of Thromboembolic Events Among Adult Patients Treated With KCENTRA® Compared With Plasma for Urgent Reversal of Vitamin K Antagonist Therapy in the Setting of Acute Major Bleeding

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Dec 18, 2014
Registry last updated
May 26, 2021

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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