Major BleedingEMERALDNCT07745933
Observational Study to Characterize Patients Experiencing Major Acute Bleeding Events During Anticoagulation Treatment With Oral Factor Xa Inhibitors.
An observational study of Major Bleeding and Major Bleeding Outcomes, run by Fadoi Foundation, Italy at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Bleeding, Major Bleeding Outcomes
- How many people
- 503 participants
- Where
- 1 siteItaly
- Study dates
- 19 Dec 2024to 29 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Not fewer than 500 consecutive patients hospitalized in Internal Medicine, Gastroenterology, Neurology and Emergency Medicine in 50 hospital centers distributed throughout Italy.
Who may be able to join
- 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
- Age >18 years
- Provision of informed consent prior to any study specific procedures
Who cannot join
- 1) None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Major Bleeding, Major Bleeding Outcomes
- Keywords
- anticoagulation with oral FXa inhibitors, observational pharmacological study, major bleeding, real-world, treatment methods for major acute bleeding events
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Incidence of Death, ICU Admission, or Bleeding-Related Rescue Surgery
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.
Measured: 3 months post-index event
Secondary outcomes (8)
Patient Age
Age of participants at baseline
Measured: Baseline (at enrollment)
Biological Sex Distribution
Number of male and female participants enrolled in the study.
Measured: Baseline (at enrollment)
Distribution of Oral FXa Inhibitors
Number of participants receiving apixaban, edoxaban, or rivaroxaban at the time of the index bleeding event.
Measured: Baseline (at enrollment)
In-Hospital Composite Incidence of Death, ICU Admission, or Rescue Surgery
Number of participants experiencing death, ICU admission, or need for bleeding-related rescue surgery during the index hospitalization period.
Measured: From index event up to hospital discharge (assessed up to 3 months)
Time to Hemostasis
Time elapsed from initiation of acute bleeding treatment to cessation of active bleeding (door-to-needle time and treatment duration).
Measured: From treatment initiation up to 24 hours
Hemostatic Efficacy Grade
Proportion of participants achieving effective hemostasis evaluated according to specific clinical criteria.
Measured: At 24 hours post-treatment
Incidence of Thromboembolic Events and Recurrent Bleeding
Number of participants experiencing ischemic stroke, myocardial infarction, pulmonary embolism, deep vein thrombosis, systemic embolism, or new bleeding episodes.
Measured: Through 3 months follow-up
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants experiencing any AE or SAE possibly related to the administered hemostatic treatments.
Measured: Through 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start19 Dec 2024
- Primary completion29 Apr 2026
- Study completion29 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fadoi Foundation, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Francesco Dentali, Prof., Study chair, Fadoi Foundation President / Department of Medicine, ASST-Settelaghi, Varese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745933
- Sponsor's protocol ID
- FADOI.03.2022
- Acronym
- EMERALD
- Status last verified
- Aug 2026
- First submitted
- 19 Jun 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
Publications
Steffel J, Collins R, Antz M, Cornu P, Desteghe L, Haeusler KG, Oldgren J, Reinecke H, Roldan-Schilling V, Rowell N, Sinnaeve P, Vanassche T, Potpara T, Camm AJ, Heidbuchel H; External reviewers. 2021 European Heart Rhythm Association Practical Guide on the Use of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation. Europace. 2021 Oct 9;23(10):1612-1676. doi: 10.1093/europace/euab065. No abstract available.
PubMed 33895845Katsanos AH, Schellinger PD, Kohrmann M, Filippatou A, Gurol ME, Caso V, Paciaroni M, Perren F, Alexandrov AV, Tsivgoulis G. Fatal oral anticoagulant-related intracranial hemorrhage: a systematic review and meta-analysis. Eur J Neurol. 2018 Oct;25(10):1299-1302. doi: 10.1111/ene.13742. Epub 2018 Jul 21.
PubMed 29953696Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowitz MD, Camm AJ, Weitz JI, Lewis BS, Parkhomenko A, Yamashita T, Antman EM. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014 Mar 15;383(9921):955-62. doi: 10.1016/S0140-6736(13)62343-0. Epub 2013 Dec 4.
PubMed 24315724
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Prospective, Multicentre, Collaborative Study, to Characterize Patients Experiencing Major Acute Bleeding Events During Anticoagulation Treatment With Oral Factor Xa Inhibitors
- ClinicalTrials.gov ID
- NCT07745933
- Acronym / sponsor ID
- EMERALD / FADOI.03.2022
- Conditions
- Major Bleeding, Major Bleeding Outcomes
- Keywords
- anticoagulation with oral FXa inhibitors, observational pharmacological study, major bleeding, real-world, treatment methods for major acute bleeding events
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 503 participants (actual)
- Lead sponsor
- Fadoi Foundation, ItalyUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- 29 Jul 2026 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Not fewer than 500 consecutive patients hospitalized in Internal Medicine, Gastroenterology, Neurology and Emergency Medicine in 50 hospital centers distributed throughout Italy.
Key inclusion criteria (5 listed)
- Patients currently receiving oral FXa inhibitors (apixaban, edoxaban, rivaroxaban), irrespective of anticoagulant dosage and duration of treatment, and presenting a major acute bleeding complication *
- Age >18 years
- Provision of informed consent prior to any study specific procedures
Key exclusion criteria (1 listed)
- 1) None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
Patient Age
Time frame: Baseline (at enrollment)
Biological Sex Distribution
Time frame: Baseline (at enrollment)
Distribution of Oral FXa Inhibitors
Time frame: 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)
Time to Hemostasis
Time frame: From treatment initiation up to 24 hours
Hemostatic Efficacy Grade
Time frame: At 24 hours post-treatment
Incidence of Thromboembolic Events and Recurrent Bleeding
Time frame: Through 3 months follow-up
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Through 3 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Results publication: PubMed 33895845Steffel J, Collins R, Antz M, Cornu P, Desteghe L, Haeusler KG, Oldgren J, Reinecke H, Roldan-Schilling V, Rowell N, Sinnaeve P, Vanassche T, Potpara T, Camm AJ, Heidbuchel H; External reviewers. 2021 European Heart Rhythm Association Practical Guide on the Use of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation. Europace. 2021 Oct 9;23(10):1612-1676. doi: 10.1093/europace/euab065. No abstract available.
- Results publication: PubMed 29953696Katsanos AH, Schellinger PD, Kohrmann M, Filippatou A, Gurol ME, Caso V, Paciaroni M, Perren F, Alexandrov AV, Tsivgoulis G. Fatal oral anticoagulant-related intracranial hemorrhage: a systematic review and meta-analysis. Eur J Neurol. 2018 Oct;25(10):1299-1302. doi: 10.1111/ene.13742. Epub 2018 Jul 21.
- Results publication: PubMed 24315724Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowitz MD, Camm AJ, Weitz JI, Lewis BS, Parkhomenko A, Yamashita T, Antman EM. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014 Mar 15;383(9921):955-62. doi: 10.1016/S0140-6736(13)62343-0. Epub 2013 Dec 4.
- Individual participant dataSharing planned: Undecided. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Dentali, Prof. study chair
Fadoi Foundation President / Department of Medicine, ASST-Settelaghi, Varese
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Bleeding and Major Bleeding Outcomes, run by Fadoi Foundation, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Incidence of Death, ICU Admission, or Bleeding-Related Rescue Surgery (time frame: 3 months post-index event). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07745933, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.