Major Bleeding, Major Bleeding Outcomes
Conditions
Keywords
anticoagulation with oral FXa inhibitors, observational pharmacological study, major bleeding, real-world, treatment methods for major acute bleeding events
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.
Interventions
None listed
Sponsors
Fadoi Foundation, Italy
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Incidence of Death, ICU Admission, or Bleeding-Related Rescue Surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Age | Baseline (at enrollment) | Age of participants at baseline |
| Biological Sex Distribution | Baseline (at enrollment) | Number of male and female participants enrolled in the study. |
| Distribution of Oral FXa Inhibitors | Baseline (at enrollment) | Number of participants receiving apixaban, edoxaban, or rivaroxaban at the time of the index bleeding event. |
| In-Hospital Composite Incidence of Death, ICU Admission, or Rescue Surgery | 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. |
| Time to Hemostasis | 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). |
| Hemostatic Efficacy Grade | At 24 hours post-treatment | Proportion of participants achieving effective hemostasis evaluated according to specific clinical criteria. |
| Incidence of Thromboembolic Events and Recurrent Bleeding | Through 3 months follow-up | Number of participants experiencing ischemic stroke, myocardial infarction, pulmonary embolism, deep vein thrombosis, systemic embolism, or new bleeding episodes. |
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Through 3 months follow-up | Number of participants experiencing any AE or SAE possibly related to the administered hemostatic treatments. |
Countries
Italy
Contacts
STUDY_CHAIRFrancesco Dentali, Prof.
Fadoi Foundation President / Department of Medicine, ASST-Settelaghi, Varese
Outcome results
None listed