New study sheds light on brain bleeds from common blood thinners
NCT ID NCT06420011
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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123 people
The number who actually took part.
- Started
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Jul 2024
- Finished
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Nov 2024
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site
Buenos Aires, Argentina
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Research Site
Joinville, Brazil
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Research Site
Porto Alegre, Brazil
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Research Site
Bogotá, Colombia
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Research Site
Mexico City, Mexico
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Research Site
Doha, Qatar
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Research Site
Mecca, Saudi Arabia
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Research Site
Riyadh, Saudi Arabia
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Research Site
Abu Dhabi, United Arab Emirates
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Research Site
Al Ain City, United Arab Emirates
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Other studies related to the condition(s) this trial covers.