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

Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02319460
• Other study ID #: BE1116_4001
• Status: Completed
• Start date: April 24, 2014
• Est. completion date: June 30, 2020

Study information

• Verified date: May 2021
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2238
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hemorrhage
• Thromboembolism

Intervention

Biological:
• Kcentra®
Kcentra®, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product that contains coagulation Factors II, VII, IX and X, and antithrombotic Proteins C and S as a lyophilized concentrate.
• Plasma

Locations

Country	Name	City	State
United States	Study Site	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
CSL Behring	Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of thromboembolic events (TEE) for patients without a recent history of TEE	The risk of confirmed thromboembolic events (TEE) will be estimated for patients without a recent history of TEE treated with Kcentra® compared to patients treated with plasma. The index date is the date of acute VKA reversal for major bleeding event.	Within 45 days after the index date
Secondary	Risk of thromboembolic events	The risk of confirmed TEE and confirmed fatal TEE will be each estimated for patients treated with Kcentra® compared to patients treated with plasma, overall and for patients in the following subgroups: Recent history of TEE; No recent history of TEE; Any history of TEE; The index date is the date of acute VKA reversal for major bleeding event.	Within 45 days after the index date
Secondary	Risk of death from any cause	The risk of death from any cause will be estimated for patients treated with Kcentra® compared to patients treated with plasma, overall and for patients in the following subgroups: Recent history of TEE; No recent history of TEE; Any history of TEE; The index date is the date of acute VKA reversal for major bleeding event.	Within 45 days after the index date
Secondary	Rates of use of VKA therapy after the index date	The rates of use of VKA therapy or other antithrombotic agents will be assessed among patients with and without any history of TEE. The index date is the date of acute VKA reversal for major bleeding event.	Within 90 days after the index date