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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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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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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