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

Completed

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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Prospective	Kcentra®	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
Prospective	Plasma	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
Retrospective	Plasma	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

Primary Outcome Measures

Name	Time	Method
Risk of thromboembolic events (TEE) for patients without a recent history of TEE	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

Name	Time	Method
Rates of use of VKA therapy after the index date	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.
Risk of thromboembolic events	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.
Risk of death from any cause	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.

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