Oakland, California 94612


Purpose:

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.


Criteria:

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)


NCT ID:

NCT02319460


Primary Contact:

Study Director
Clinical Epidemiologist
CSL Behring

Clinical Trial Disclosure Manager
Email: clinicaltrials@cslbehring.com


Backup Contact:

N/A


Location Contact:

Oakland, California 94612
United States

Use Central Contact

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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