Evaluating a treatment for brain bleeding related to blood thinners
Evaluation of 4-Factor PCC in DOAC-associated Intracranial Hemorrhage
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Methodist Health System Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06096051 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Dallas, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.