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
Information source: CSL Behring
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hemorrhage
Intervention: Kcentra® (Biological); Plasma (Biological)
Phase: N/A
Status: Recruiting
Sponsored by: CSL Behring Official(s) and/or principal investigator(s): Clinical Epidemiologist, Study Director, Affiliation: CSL Behring Alan S. Go, MD, Principal Investigator, Affiliation: Kaiser Permanente Kristi Reynolds, PhD, MPH, Principal Investigator, Affiliation: Kaiser Permanente
Overall contact: Clinical Trial Disclosure Manager, Email: clinicaltrials@cslbehring.com
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.
Clinical Details
Official title: 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
Study design: Observational Model: Cohort
Primary outcome: Risk of thromboembolic events (TEE) for patients without a recent history of TEE
Secondary outcome: Risk of thromboembolic eventsRisk of death from any cause Rates of use of VKA therapy after the index date
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
Clinical Trial Disclosure Manager, Email: clinicaltrials@cslbehring.com
Study Site, Oakland, California 94612, United States; Recruiting Use Central Contact Alan S. Go, MD, Principal Investigator Kristi Reynolds, PhD, MPH, Principal Investigator
Additional Information
Starting date: March 2014
Last updated: June 29, 2015
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