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

N/ACompletedNCT02319460

CSL Behring2,238 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,238

Conditions

Hemorrhage

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

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.

Time frame: Within 45 days after the index date

Secondary Outcomes

Risk of thromboembolic events

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.

Time frame: Within 45 days after the index date

Risk of death from any cause

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.

Time frame: Within 45 days after the index date

Rates of use of VKA therapy 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.

Time frame: Within 90 days after the index date

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes