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

AstraZeneca

Status: Completed

Conditions: Anticoagulant-related Major Bleed

Treatments: Drug: Andexanet alfa; Drug: 4F-PCC

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05548777

D9603R00004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,480 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

5,480 participants in 1 patient group

Patients hospitalized for an anticoagulation-related major bleed

Treatment:

Drug: Andexanet alfa

Drug: 4F-PCC