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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

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ClinicalTrials.gov Identifier: NCT02319460
Recruitment Status : Recruiting
First Posted : December 18, 2014
Last Update Posted : March 26, 2018
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
CSL Behring

Brief Summary:
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.

Condition or disease Intervention/treatment
Hemorrhage Biological: Kcentra® Biological: Plasma

Study Type : Observational
Estimated Enrollment : 3450 participants
Observational Model: Cohort
Time Perspective: Other
Official 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
Actual Study Start Date : April 24, 2014
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Vitamin K
Drug Information available for: Menadione

Group/Cohort Intervention/treatment
Retrospective
Retrospective cohort of adults hospitalized for major bleeding during 2008 to 2013 who receive plasma for urgent reversal of acquired coagulation factor deficiency induced by oral VKA therapy
Biological: Plasma
Prospective
Prospective parallel cohort of adults hospitalized for major bleeding during 2014 to 2020 who either receive Kcentra® or plasma for urgent reversal of acquired coagulation factor deficiency induced by oral VKA therapy
Biological: Kcentra®
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

Biological: Plasma



Primary Outcome Measures :
  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 Outcome Measures :
  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:

    • No history of TEE
    • Recent history of TEE
    • Remote 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:

    • No history of TEE
    • Recent history of TEE
    • Remote 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult members of the Kaiser Permanente Northern and Southern California health care delivery systems, receiving chronic warfarin therapy and meeting study eligibility criteria.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319460


Contacts
Contact: Clinical Trial Disclosure Manager clinicaltrials@cslbehring.com

Locations
United States, California
Study Site Recruiting
Oakland, California, United States, 94612
Contact: Use Central Contact         
Principal Investigator: Alan S. Go, MD         
Principal Investigator: Kristi Reynolds, PhD, MPH         
Sponsors and Collaborators
CSL Behring
Kaiser Permanente
Investigators
Study Director: Clinical Epidemiologist CSL Behring
Principal Investigator: Alan S. Go, MD Kaiser Permanente
Principal Investigator: Kristi Reynolds, PhD, MPH Kaiser Permanente

Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT02319460     History of Changes
Other Study ID Numbers: BE1116_4001
First Posted: December 18, 2014    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018

Keywords provided by CSL Behring:
Vitamin K Reversal Antagonist Therapy of Acute Major Bleeding
Warfarin Reversal

Additional relevant MeSH terms:
Hemorrhage
Thromboembolism
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Vitamins
Vitamin K
Thrombin
Protein C
Protein S
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Anticoagulants
Fibrinolytic Agents