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| Name | Class |
|---|---|
| Kaiser Permanente | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective | 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 |
| |
| Prospective | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kcentra® | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
The index date is the date of acute VKA reversal for major bleeding event. | Within 45 days after the index date |
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Inclusion Criteria:
Exclusion Criteria:
Patients will be excluded from the primary analyses if they:
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Adult members of the Kaiser Permanente Northern and Southern California health care delivery systems, receiving chronic warfarin therapy and meeting study eligibility criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Epidemiologist | CSL Behring | Study Director |
| Alan S. Go, MD | Kaiser Permanente | Principal Investigator |
| Kristi Reynolds, PhD, MPH | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Site | Oakland | California | 94612 | United States |
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|
| Plasma | Biological |
|
| 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:
The index date is the date of acute VKA reversal for major bleeding event. | 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. | Within 90 days after the index date |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005164 | Factor IX |
| C525441 | factor IX, factor VII, factor X, prothrombin drug combination |
| ID | Term |
|---|---|
| D004792 | Enzyme Precursors |
| D045762 | Enzymes and Coenzymes |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
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