Observational Study to Characterize Patients Experiencing Major Acute Bleeding Events During Anticoagulation Treatment With Oral Factor Xa Inhibitors. (EMERALD)

August 3, 2026 updated by: Fadoi Foundation, Italy

Observational, Prospective, Multicentre, Collaborative Study, to Characterize Patients Experiencing Major Acute Bleeding Events During Anticoagulation Treatment With Oral Factor Xa Inhibitors

Oral factor Xa inhibitors are widely used for the prevention of cardioembolic events in patients with atrial fibrillation and for the treatment of venous thromboembolism, thanks to their good efficacy/safety ratio compared to vitamin K antagonists. However, major bleeding remains a potentially life-threatening event, a relevant complication and real-world treatments are still heterogeneous and there are limited data available in the literature.It is therefore considered particularly important to collect and analyze information on how major bleeding complications are treated in clinical practice and to examine the outcomes.

The objective of this study is to implement a prospective, computerized collection of clinical information, as a basis for identifying and analysing patient characteristics and treatment methods for major acute bleeding events occurring during anticoagulation with oral FXa inhibitors (apixaban, edoxaban, rivaroxaban) documenting the short-term clinical outcomes and those 3 months (90 days) after the acute event.

The main questions the study aims to answer are:

  • What are the severe clinical outcomes for these patients, specifically the composite incidence of death, the need for Intensive Care Unit (ICU) admission, or the need for bleeding-related rescue surgery?
  • What are the characteristics of the patients experiencing these events, and how are these bleeding complications managed in real-world clinical practice? Because this is an observational study, there are no experimental pharmacological interventions. Participants will receive standard clinical care based on the normal practice of each participating hospital. Data will be evaluated during the acute hospitalization phase and at a 3-month (90 days) follow-up after the initial event The study is coordinated by FADOI (Italian Society of Hospital Internal Medicine) in collaboration with AIGO (Italian Association of Hospital Gastroenterologists and Digestive Endoscopists), AII-ISA (Italian Stroke Association) and SIMEU (Italian Society of Emergency Medicine); for this the study involves not fewer than 500 consecutive patients hospitalized in Internal Medicine, Gastroenterology, Neurology and Emergency Medicine in 50 hospital centers distributed throughout Italy.

This is a prospective, observational, multicentre, pharmacological, collaborative study. Information will be collected on patients experiencing major acute bleeding events, with details of the treatment given and the clinical outcome, both in the acute phase and 3 months (90 days) after the index event. Given the observational nature of the study, there are no indications regarding the type of patients' management and/or treatment to be performed. However, major bleeding remains a relevant complication and real-world treatments are still heterogeneous and this study aims to prospectively collect data on the management of these events, including the use of available therapies.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
503

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20157
        • Antonella Valerio - Centro Studi FADOI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Not fewer than 500 consecutive patients hospitalized in Internal Medicine, Gastroenterology, Neurology and Emergency Medicine in 50 hospital centers distributed throughout Italy.

Description

Inclusion Criteria:

  1. Patients currently receiving oral FXa inhibitors (apixaban, edoxaban, rivaroxaban), irrespective of anticoagulant dosage and duration of treatment, and presenting a major acute bleeding complication *

    * Events that qualify patients for the study:

    • Major spontaneous or post-traumatic bleeding, in accordance with the International Society on Thrombosis and Haemostasis (ISTH) definition

  2. Age >18 years
  3. Provision of informed consent prior to any study specific procedures

Exclusion Criteria:

1) None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite Incidence of Death, ICU Admission, or Bleeding-Related Rescue Surgery
Time Frame: 3 months post-index event
Number of participants experiencing at least one of the following events: all-cause mortality, admission to the Intensive Care Unit (ICU), or need for bleeding-related rescue surgery following an acute major bleeding event while on oral FXa inhibitor therapy.
3 months post-index event

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Age
Time Frame: Baseline (at enrollment)
Age of participants at baseline
Baseline (at enrollment)
Biological Sex Distribution
Time Frame: Baseline (at enrollment)
Number of male and female participants enrolled in the study.
Baseline (at enrollment)
Distribution of Oral FXa Inhibitors
Time Frame: Baseline (at enrollment)
Number of participants receiving apixaban, edoxaban, or rivaroxaban at the time of the index bleeding event.
Baseline (at enrollment)
In-Hospital Composite Incidence of Death, ICU Admission, or Rescue Surgery
Time Frame: From index event up to hospital discharge (assessed up to 3 months)
Number of participants experiencing death, ICU admission, or need for bleeding-related rescue surgery during the index hospitalization period.
From index event up to hospital discharge (assessed up to 3 months)
Time to Hemostasis
Time Frame: From treatment initiation up to 24 hours
Time elapsed from initiation of acute bleeding treatment to cessation of active bleeding (door-to-needle time and treatment duration).
From treatment initiation up to 24 hours
Hemostatic Efficacy Grade
Time Frame: At 24 hours post-treatment
Proportion of participants achieving effective hemostasis evaluated according to specific clinical criteria.
At 24 hours post-treatment
Incidence of Thromboembolic Events and Recurrent Bleeding
Time Frame: Through 3 months follow-up
Number of participants experiencing ischemic stroke, myocardial infarction, pulmonary embolism, deep vein thrombosis, systemic embolism, or new bleeding episodes.
Through 3 months follow-up
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Through 3 months follow-up
Number of participants experiencing any AE or SAE possibly related to the administered hemostatic treatments.
Through 3 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fadoi Foundation, Italy

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Francesco Dentali, Prof., Fadoi Foundation President / Department of Medicine, ASST-Settelaghi, Varese

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 19, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 29, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 29, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FADOI.03.2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

there is not a specific reason, simply because it is a study in collaboration with 4 different Italian scientific societies, this decision will also have to be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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