Evaluating a treatment for brain bleeding related to blood thinners
Official title: Evaluation of 4-Factor PCC in DOAC-associated Intracranial Hemorrhage
Run by Methodist Health System · NCT06096051 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing how well a specific treatment works for adults with brain bleeding who have been on blood thinners to see if it helps them recover better.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Methodist Health System Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06096051 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who have experienced ICH and were treated with 4F-PCC after using rivaroxaban or apixaban.
✕Probably not a fit
Patients who have used warfarin or dabigatran, are under 18 years of age, pregnant, or incarcerated will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on patients with intracranial hemorrhage (ICH) who have been treated with a fixed-dose 4-factor prothrombin complex concentrate (4F-PCC) after using direct oral anticoagulants (DOACs) like rivaroxaban or apixaban. It aims to assess the outcomes of ICH in patients who received this treatment, particularly looking at the effects on progression of bleeding, need for neurosurgery, and overall survival. The study will include adults aged 18 and older who were admitted to the Methodist Health System between July 2018 and May 2023. By analyzing these cases, the study seeks to enhance understanding of optimal anticoagulant reversal in ICH patients.
Why it matters
Potential benefit: If successful, this study could improve treatment protocols for patients experiencing brain bleeding due to anticoagulant use, potentially leading to better outcomes.
How similar studies have gone: While this approach is based on existing knowledge of anticoagulant reversal, the specific use of 4F-PCC in this context is still being evaluated and may provide novel insights.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Methodist Dallas Medical Center
Dallas, Texas, United States Recruiting
Study contacts
- Principal investigator: Tamara Reiter, PharmD — Methodist Midlothian Medical Center
- Study coordinator: Bethany Brauer, MPH
- Email: MHSIRB@mhd.com
- Phone: 214-947-1281
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Febuxostat for conservatively managed intracranial hemorrhage
This study tests whether febuxostat can improve outcomes for adults with intracranial hemorrhage who are managed without surgery.
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Atorvastatin for primary intracerebral hemorrhage
This trial will see if adding atorvastatin to usual care helps adults (18–80) who have a spontaneous intracerebral hemorrhage and are treated within 3–24 hours of symptom onset.
-
IRRAflow continuous irrigation to clear blood and infection inside the head
This trial tests whether the IRRAflow system, which continuously irrigates and drains the brain, clears intracranial blood and treats ventriculitis or abscess better than standard external ventricular drains in adults.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.