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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

NCT02319460 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2238

Last updated 2021-05-26

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Kcentra®

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.

BIOLOGICAL

Plasma

Sponsors & Collaborators

  • Kaiser Permanente

    collaborator OTHER

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Clinical Epidemiologist · CSL Behring

  • Alan S. Go, MD · Kaiser Permanente

  • Kristi Reynolds, PhD, MPH · Kaiser Permanente

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-24
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02319460 on ClinicalTrials.gov