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

NCT07745933 | Active Not Recruiting DMC

• 1 other identifier: FADOI.03.2022
• Study Type: observational
• Target: 503
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months post-index event

Secondary Outcomes (8)

• Patient Age

  Baseline (at enrollment)

• Biological Sex Distribution

  Baseline (at enrollment)

• Distribution of Oral FXa Inhibitors

  Baseline (at enrollment)

• In-Hospital Composite Incidence of Death, ICU Admission, or Rescue Surgery

  From index event up to hospital discharge (assessed up to 3 months)

• Time to Hemostasis

  From treatment initiation up to 24 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \) None

Sponsors & Collaborators

• Fadoi Foundation, Italy: lead
• AstraZeneca: collaborator

Study Sites (1)

Antonella Valerio - Centro Studi FADOI

Milan, 20157, Italy

Location

Related Publications (3)

• 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.

  PMID: 33895845 RESULT

• Katsanos 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.

  PMID: 29953696 RESULT

• Ruff 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.

  PMID: 24315724 RESULT

Study Officials

• Francesco Dentali, Prof.

  Fadoi Foundation President / Department of Medicine, ASST-Settelaghi, Varese

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: August 4, 2026
• Study Start: December 19, 2024
• Primary Completion: April 29, 2026
• Study Completion: July 29, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-08

Locations

IT (1)