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

Completed

• Conditions: Anticoagulant-related Major Bleed
• Interventions: Drug: Andexanet alfa; Drug: 4F-PCC

• Registration Number: NCT05548777
• Lead Sponsor: AstraZeneca

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.

Study Timeline

• Study First Submitted: 2022-08-26
• Study Start: 2022-09-15
• Study First Submitted QC: 2022-09-19
• Study First Posted: 2022-09-21
• Primary Completion: 2022-12-20
• Study Completion: 2022-12-20
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5480

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients hospitalized for an anticoagulation-related major bleed	Andexanet alfa	-
Patients hospitalized for an anticoagulation-related major bleed	4F-PCC	-

Primary Outcome Measures

Name	Time	Method
Mortality	During hospitalisation, approximately 6 days	In-hospital mortality

Trial Locations

Locations (1)

Research Site; 🇺🇸 Agoura Hills, California, United States