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Brain bleed breakthrough? new study tests antidote for blood thinner patients

NCT ID NCT05127941

Knowledge-focused Sponsor: University Hospital, Essen 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 observed 141 people in German stroke units who had a brain bleed while taking the blood thinners rivaroxaban or apixaban. Researchers wanted to see if giving the reversal drug andexanet alfa could stop the bleed from getting bigger. They tracked changes in bleed size on brain scans and checked patients' recovery and survival up to 90 days later.

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

141 people

The number who actually took part.

Started

Dec 2021

Finished

May 2025

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

Patients with anticoagulating therapy with rivaroxaban or apixaban admitted with a clinically symptomatic ICH will be included in the study if they have been treated with andexanet alfa. A repeat CT or MRI between 12-72h after initial imaging to assess size and volume of bleeding corresponds to the standard treatment. The option to include patients under anticoagulating therapy edoxaban will be evaluated during the course of the study in case a marketing authorization of andexanet alfa for patients under edoxaban will be received.

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: * Age ≥18 years at enrollment * Patients willing and able to provide written informed consent for data transmission. For patients who are not legally competent to sign this informed consent for data transmission exceptions/special cases are defined (details provided in the study protocol) * Patients with primary intracranial hemorrhage as confirmed with CT or MRI. * Patients under effective anticoagulation treatment with rivaroxaban or apixaban at the time of admission, according to the judgement of treating physician and determined using Point-of-care (PoC) anti-factor Xa (fXa) assays or laboratory-based anti-fXa measurement. * Patients treated with andexanet alfa * Signed informed consent as soon as possible after start of symptoms of initial ICH event, but before discharge Exclusion Criteria: * Start of symptoms of initial ICH event \> 24 h before admission to hospital

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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.

Intracranial hemorrhages

Contacts and locations

Locations

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Universitätsklinikum Tübingen

    Tübingen, 72076, Germany

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