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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 : April 1, 2019
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
CSL Behring

Tracking Information
First Submitted Date December 15, 2014
First Posted Date December 18, 2014
Last Update Posted Date April 1, 2019
Actual Study Start Date April 24, 2014
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 17, 2014)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 17, 2014)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Hemorrhage
Intervention
  • 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
Study Groups/Cohorts
  • 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
    Intervention: 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
    Interventions:
    • Biological: Kcentra®
    • Biological: Plasma
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 17, 2014)
3450
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Clinical Trial Disclosure Manager clinicaltrials@cslbehring.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02319460
Other Study ID Numbers BE1116_4001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party CSL Behring
Study Sponsor CSL Behring
Collaborators 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
PRS Account CSL Behring
Verification Date March 2019