Follow-up on recovery outcomes after intracerebral hemorrhage
Recovery and Outcomes From Stroke (ROSE) Sub-study of Genetic and Environmental Risk Factors for Hemorrhagic Stroke
This study is tracking 500 people who have had a type of brain bleed to see how well they recover and what factors might affect their recovery over the first six months after the stroke.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Cincinnati Academic / other |
| Locations | 8 sites (Chicago, Illinois and 7 other locations) |
| Trial ID | NCT04007757 on ClinicalTrials.gov |
What this trial studies
This observational study will track 500 cases of deep and lobar intracerebral hemorrhage to assess recovery outcomes through advanced neuroimaging and evaluations of motor and cognitive function at baseline, 3 months, and 6 months post-stroke. The aim is to identify predictors of recovery and any progressive cognitive or functional impairments. By focusing on the unique aspects of hemorrhagic stroke, the study seeks to provide a deeper understanding of the injury mechanisms and recovery processes involved. This research builds on existing prospective studies to enhance the understanding of outcomes in hemorrhagic stroke patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older who have experienced deep, subcortical, or lobar intracerebral hemorrhage without other complicating factors.
Not a fit: Patients with brainstem or cerebellar intracerebral hemorrhage, or those severely affected by the ICH, are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery strategies and better management of patients who suffer from intracerebral hemorrhage.
How similar studies have performed: While there have been studies on stroke outcomes, this specific focus on hemorrhagic stroke and its predictors is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or greater, fulfillment of the criteria for Deep, Subcortical or Lobar Intracerebral Hemorrhage (ICH) * No evidence of trauma, vascular malformation or aneurysm, or brain tumor as a cause of ICH. * Ability of the patient or legal representative to provide informed consent Exclusion Criteria: * Brainstem or Cerebellar ICH * Patients Severely Affected by the ICH, Early Mortality, Hospice, or Withdraw of Care NOT eligible for ROSE
Where this trial is running
Chicago, Illinois and 7 other locations
- University of Illinois Chicago — Chicago, Illinois, United States (Recruiting)
- Baptist Health Louisville — Louisville, Kentucky, United States (Recruiting)
- University of Maryland — Baltimore, Maryland, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Columbia University — New York, New York, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)
- Houston Methodist — Houston, Texas, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Daniel Woo, MD, MS — University of Cincinnati
- Study coordinator: Tyler P Behymer, BS
- Email: Tyler.behymer@uc.edu
- Phone: 513-558-0122
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.