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
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/3/2019 |
| Start Date: | April 24, 2014 |
| End Date: | June 2020 |
| Contact: | Clinical Trial Disclosure Manager |
| Email: | clinicaltrials@cslbehring.com |
An Observational Cohort Study of the Risk of Thromboembolic Events Among Adult Patients Treated With KCENTRA® Compared With Plasma for Urgent Reversal of Vitamin K Antagonist Therapy in the Setting of Acute Major Bleeding
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.
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.
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)
We found this trial at
1
site
Oakland, California 94612
Principal Investigator: Alan S. Go, MD
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