Hemorrhage

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 | PHASE 3 | OBSERVATIONAL

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.

1 Sites

2238 Participants

Recruiting

18 Years to 65 Years

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Study Site

Oakland,California,United States,94612

Study Eligibility 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)

Additional Studies

Additional studies can be found at ClinicalTrials.gov