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

NCT ID: NCT05548777

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5480 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-15

Study Completion Date

2022-12-20

Brief Summary

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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

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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.

Conditions

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Anticoagulant-related Major Bleed

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients hospitalized for an anticoagulation-related major bleed

Andexanet alfa

Intervention Type DRUG

Andexanet alfa

4F-PCC

Intervention Type DRUG

Four-Factor Prothrombin Complex Concentrate (4F-PCC)

Interventions

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Andexanet alfa

Andexanet alfa

Intervention Type DRUG

4F-PCC

Four-Factor Prothrombin Complex Concentrate (4F-PCC)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Outcomes Insights

UNKNOWN

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Agoura Hills, California, United States

Site Status

Countries

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United States

References

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Dobesh PP, Coleman CI, Danese M, Lesen E, Chang RC, Odelade O, Fermann GJ. Management of factor Xa inhibitor-related traumatic non-intracranial bleeding events with andexanet alfa or four-factor prothrombin complex concentrate in a US multicenter observational study. J Am Coll Emerg Physicians Open. 2024 Nov 7;5(6):e13333. doi: 10.1002/emp2.13333. eCollection 2024 Dec.

Reference Type DERIVED
PMID: 39524040 (View on PubMed)

Dobesh PP, Fermann GJ, Christoph MJ, Koch B, Lesen E, Chen H, Lovelace B, Dettling T, Danese M, Ulloa J, Danese S, Coleman CI. Lower mortality with andexanet alfa vs 4-factor prothrombin complex concentrate for factor Xa inhibitor-related major bleeding in a U.S. hospital-based observational study. Res Pract Thromb Haemost. 2023 Aug 30;7(6):102192. doi: 10.1016/j.rpth.2023.102192. eCollection 2023 Aug.

Reference Type DERIVED
PMID: 37753225 (View on PubMed)

Related Links

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https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9603R00004&attachmentIdentifier=bfb47b8f-f18d-454a-a13a-11c9e45da538&fileName=CSR_synopsis_Acute_Major_Bleed_Chart_Audit_D9603R00004.pdf&versionIdentifier=

Redacted CSR synopsis\_D9603R00004

Other Identifiers

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D9603R00004

Identifier Type: -

Identifier Source: org_study_id