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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05548777
• Collaborator: Outcomes Insights (Other)
• Enrollment: 5,000
• Anticipated Duration (Months): 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anticoagulant-related Major Bleed	Drug: Andexanet alfa; Drug: 4F-PCC

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 Design

• Study Type: Observational
• Anticipated Enrollment: 5000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Andexanet Alfa and 4F-PCC Use in Patients Hospitalised With an Anticoagulant-related Major Bleed
• Anticipated Study Start Date: Sep 21, 2022
• Anticipated Primary Completion Date: Nov 30, 2022
• Anticipated Study Completion Date: Nov 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients hospitalized for an anticoagulation-related major bleed	Drug: Andexanet alfa; Andexanet alfa; Drug: 4F-PCC; Four-Factor Prothrombin Complex Concentrate (4F-PCC)

Outcome Measures

Primary Outcome Measures

1. Mortality [During hospitalisation, approximately 6 days]

   In-hospital mortality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 130 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AstraZeneca
• Outcomes Insights

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT05548777
• Other Study ID Numbers: D9603R00004
• First Posted: Sep 21, 2022
• Last Update Posted: Sep 21, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Hemorrhage

Study Results

No Results Posted as of Sep 21, 2022