Hemorrhage
Conditions
Keywords
Vitamin K Reversal Antagonist Therapy of Acute Major Bleeding, Warfarin Reversal
Brief 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.
Interventions
BIOLOGICALKcentra®
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.
BIOLOGICALPlasma
Sponsors
Kaiser Permanente
CSL Behring
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk of thromboembolic events (TEE) for patients without a recent history of TEE | Within 45 days after the index date | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk of thromboembolic events | Within 45 days after the index date | 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. |
| Risk of death from any cause | Within 45 days after the index date | 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. |
| Rates of use of VKA therapy after the index date | Within 90 days 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. |
Countries
United States
Outcome results
None listed