Andexanet Alfa and 4F-PCC Use in Patients Hospitalised With an Anticoagulant-related Major Bleed

Study Overview
=================
Brief Summary
-----------------
This is an observational study based on data collected via an audit of electronic medical charts. The study population will include adult US patients treated with andexanet alfa or 4F-PCC during a hospitalization for an anticoagulation-related major bleed, and their characteristics, treatments and outcomes will be described.

Detailed Description
-----------------
This observational study will include adult US patients treated with andexanet alfa or 4F-PCC during a hospitalization for an anticoagulation-related major bleed. Data will be collected via an audit of electronic medical charts. The primary objectives are to describe the patients' characteristics, treatments and outcomes, including length of stay and in-hospital mortality. Secondary objectives include subgroup analyses, including by bleed location. Potential differences between patients treated with andexanet alfa versus 4F-PCC, and potential differences in patient characteristics over time, will be assessed. If this assessment confirms that treatment groups can be adequately balanced and that patient characteristics have not substantially changed over time (i.e. no channeling bias is observed), the risk of in-hospital mortality with andexanet alfa versus 4F-PCC will be assessed in a comparative effectiveness analysis. If treatment groups cannot be balanced or clear signs of channelling bias are observed, the comparative analyses will be considered unfeasible and will not be performed.

Official Title
-----------------
Andexanet Alfa and 4F-PCC Use in Patients Hospitalised With an Anticoagulant-related Major Bleed

Conditions
-----------------
Anticoagulant-related Major Bleed

Intervention / Treatment
-----------------
* Drug: Andexanet alfa
* Drug: 4F-PCC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICD-10-CM diagnosis code of D68.32 (Hemorrhagic disorder due to extrinsic circulating anticoagulants) as part of an inpatient admission Taking either an oral FXa inhibitor or enoxaparin at the time of hospitalization for their bleeding event Treated with either andexanet alfa or 4F-PCC during the hospitalization for their bleeding event Had documented discharge disposition Exclusion Criteria: Less than 18 years old Treated with both andexanet alfa and 4F-PCC during the hospitalization for their bleeding event

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 130 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients hospitalized for an anticoagulation-related major bleed<br> | Drug: Andexanet alfa<br>* Andexanet alfa<br>Drug: 4F-PCC<br>* Four-Factor Prothrombin Complex Concentrate (4F-PCC)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | In-hospital mortality | During hospitalisation, approximately 6 days |