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

CSL Behring

Status: Completed

Conditions: Hemorrhage

Treatments: Biological: Plasma; Biological: Kcentra®

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02319460

BE1116_4001

Details and patient eligibility

About

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.

Enrollment: 2,238 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

2,238 participants in 2 patient groups

Retrospective

Description:

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

Treatment:

Biological: Plasma

Prospective

Description:

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

Treatment:

Biological: Kcentra®

Biological: Plasma