NCT05548777

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,480

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

September 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

August 26, 2022

Last Update Submit

November 22, 2023

Conditions

Anticoagulant-related Major Bleed

Outcome Measures

Primary Outcomes (1)

  • Mortality

    In-hospital mortality

    During hospitalisation, approximately 6 days

Study Arms (1)

Patients hospitalized for an anticoagulation-related major bleed

Drug: Andexanet alfaDrug: 4F-PCC

Interventions

Andexanet alfaDRUG

Andexanet alfa

Patients hospitalized for an anticoagulation-related major bleed
4F-PCCDRUG

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

Patients hospitalized for an anticoagulation-related major bleed

Eligibility Criteria

Age18 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult US patients treated with andexanet alfa or 4F-PCC during a hospitalization for an anticoagulation-related major bleed

You may qualify if:

  • 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

You may not qualify if:

  • Less than 18 years old
  • Treated with both andexanet alfa and 4F-PCC during the hospitalization for their bleeding event

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Agoura Hills, California, 91301, United States

Location

Related Publications (2)

  • 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.

    PMID: 39524040DERIVED

  • 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.

    PMID: 37753225DERIVED

Related Links

MeSH Terms

Interventions

PRT064445Factor IX

Intervention Hierarchy (Ancestors)

Enzyme PrecursorsEnzymes and CoenzymesBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsProtein PrecursorsBiological Factors

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2022

First Posted

September 21, 2022

Study Start

September 15, 2022

Primary Completion

December 20, 2022

Study Completion

December 20, 2022

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AstraZeneca disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. AstraZeneca will accept request for IPD, but this does not mean requests will be granted and data shared.

Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria
If and when a request has been approved, AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
More information

Locations

US(1)