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Can we predict and improve outcomes of major bleeding on blood thinners?

NCT ID NCT07745933

Knowledge-focused Sponsor: Fadoi Foundation, Italy Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This study follows over 500 patients in Italy who experience major bleeding while taking oral factor Xa inhibitors (apixaban, edoxaban, rivaroxaban), commonly used to prevent blood clots. The goal is to describe these patients, how their bleeding is treated in real-world practice, and their outcomes during hospitalization and 90 days later. By collecting this information, researchers hope to identify patterns that could improve management and care for this serious complication.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
This study could help doctors better understand and manage major bleeding in patients taking blood thinners, potentially improving care and outcomes.
What could go wrong
As an observational study, it cannot prove cause and effect. Results may not apply to all patients or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

503 people

The number who actually took part.

Started

Dec 2024

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Major bleeding Major bleeding outcomes

Contacts and locations

Locations

  • Antonella Valerio - Centro Studi FADOI

    Milan, 20157, Italy

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