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
Status: Completed
Location: See location...
Intervention Type: Biological
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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
Locations
United States
California
Study Site
Oakland
Time Frame
Start Date: 2014-04-24
Completion Date: 2020-06-30
Participants
Target number of participants: 2238
Treatments
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
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
Authors
Kristi Reynolds, Alan S. Go
Sponsors
Leads: CSL Behring
Collaborators: Kaiser Permanente