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
Completed
Conditions studied: Hemorrhage
In brief
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.
Key facts
- Study ID
- NCT02319460
- Run by
- CSL Behring
- People needed
- 2238
- Starts
- 2014-04-24
- Expected to finish
- 2020-06-30
- Last updated by the study team
- 2021-05-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Study Site — Oakland, California, United States
Full record on ClinicalTrials.gov
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