CompletedNot Applicable

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

United States2,238 participantsStarted 2014-04-24

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

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

Timeframe: Within 45 days after the index date

Trial details

NCT IDNCT02319460

SponsorCSL Behring

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-06-30

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