An observational study in Hemorrhage, sponsored by CSL Behring. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-26.
Sponsored by CSL Behring · Observational
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.
818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.
This study's enrollment of 2,238 is above the median of 500 across 344 observational studies indexed under Thromboembolism.
Browse Thromboembolism studies →CSL Behring is the lead sponsor of 142 studies on the registry; 18 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 17 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult members of the Kaiser Permanente Northern and Southern California health care delivery systems, receiving chronic warfarin therapy and meeting study eligibility criteria.
Exclusion Criteria:
Patients will be excluded from the primary analyses if they:
Retrospective cohort of adults hospitalized for major bleeding during 2008 to 2013 who receive plasma for urgent reversal of acquired coagulation factor deficiency induced by oral VKA therapy
Biological: Plasma
Prospective parallel cohort of adults hospitalized for major bleeding during 2014 to 2020 who either receive Kcentra® or plasma for urgent reversal of acquired coagulation factor deficiency induced by oral VKA therapy
Biological: Kcentra® · Biological: Plasma
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.
Also known as: Prothrombin Complex Concentrate (Human), Beriplex
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.
Time frame: Within 45 days after the index date
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.
Time frame: Within 45 days after the index date
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.
Time frame: Within 45 days after the index date
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.
Time frame: Within 90 days after the index date
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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CSL Behring