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Could a single fixed dose stop brain bleeds in patients on blood thinners?

NCT ID NCT06096051

Disease control Sponsor: Methodist Health System 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study looked at whether a fixed dose of a drug called 4F-PCC is safe and effective for reversing the effects of common blood thinners (rivaroxaban or apixaban) in patients with brain bleeding. Researchers compared this fixed-dose approach to the standard weight-based dosing in 76 adults. The goal was to see if the simpler fixed dose could control bleeding just as well.

What this could mean

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

Active substance
4-factor prothrombin complex concentrate (4F-PCC)
What this could lead to
If successful, this could simplify emergency treatment for brain bleeding in patients on common blood thinners, potentially saving lives.
What could go wrong
This is a small, completed study with only 76 participants. Results may not apply to all patients, and the fixed dose may not work as well as weight-based dosing in some cases.

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

76 people

The number who actually took part.

Started

Jun 2023

Finished

Jun 2024

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 18 years of age * ICH (traumatic and spontaneous) * Administration of at least one dose of 4F-PCC * Admitted to the MHS between July 1, 2018 and May 30, 2023 * Rivaroxaban or apixaban use prior to admission

Ages

18 to 75 years

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: * • ≥18 years of age * ICH (traumatic and spontaneous) * Administration of at least one dose of 4F-PCC * Admitted to the MHS between July 1, 2018 and May 30, 2023 * Rivaroxaban or apixaban use prior to admission Exclusion Criteria: * • Warfarin or dabigatran use prior to admission * Prisoners * Pregnancy * \<18 years of age

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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 hemorrhage

Contacts and locations

Locations

  • Methodist Dallas Medical Center

    Dallas, Texas, 75203, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.