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New study sheds light on brain bleeds from common blood thinners

NCT ID NCT06420011

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked back at medical records of 123 adults hospitalized with a brain bleed while taking a type of blood thinner called a factor Xa inhibitor. The goal was to understand what happens to these patients and how they are treated in countries where a specific reversal drug is not available. The findings will help doctors make better decisions and improve care for people on these medications.

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

123 people

The number who actually took part.

Started

Jul 2024

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

The study will recruit 350 adult patients (age ≥18 years at the time of hospital admission) hospitalised patients with FXa inhibitors-related ICH from a total of 20-25 sites from Asia-Pacific Region, Latin America, and the MEA, where FXa inhibitors specific reversal agent is not approved locally.

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: * Men and women ≥ 18 years of age at the time of hospital admission. * Patients presented with a spontaneous or traumatic haemorrhage into any intracranial compartment. The diagnosis of ICH will be based on Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan and according to the ICD-10-CM diagnosis code. * Patients who were determined in the medical records to have taken a dose of oral FXa inhibitors within 24 hrs before hospital presentation that warranted reversal of anticoagulant activities. Exclusion Criteria: * Patients who were treated with andexanet alfa. * Patients who were enrolled in any clinical trials during the study period.

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Conditions

The condition(s) this trial relates to.

intracerebral hemorrhage Intracranial Hemorrhages

As listed by the trial registrant

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

Contacts and locations

Locations

  • Research Site

    Buenos Aires, Argentina

  • Research Site

    Joinville, Brazil

  • Research Site

    Porto Alegre, Brazil

  • Research Site

    Bogotá, Colombia

  • Research Site

    Mexico City, Mexico

  • Research Site

    Doha, Qatar

  • Research Site

    Mecca, Saudi Arabia

  • Research Site

    Riyadh, Saudi Arabia

  • Research Site

    Abu Dhabi, United Arab Emirates

  • Research Site

    Al Ain City, United Arab Emirates

More trials for these conditions

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