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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 events

Risk 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

Page last updated: August 20, 2015

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