Evaluating a new method for draining fluid and blood in brain hemorrhages
Use of Active Fluid Exchange to Therapeutically Treat Intracranial Bleeding and Infection
This study is testing a new device for draining fluid and blood from the brain to see if it works better than the standard method for patients with brain hemorrhages.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT05649904 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of the IRRAflow device, which uses Active Controlled Irrigation and Drainage, compared to the traditional Passive External Ventricular Drainage (EVD) method. Patients with conditions such as intraventricular hemorrhage, subarachnoid hemorrhage, subdural hematoma, and ventriculitis will be randomly assigned to receive either treatment. Participants will be monitored for one month post-procedure to evaluate the outcomes of each approach. The study seeks to determine if the new method provides better results in managing these serious conditions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who require drainage for specific brain hemorrhage conditions.
Not a fit: Patients with fixed and dilated pupils, pregnant women, or those with certain blood disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes for patients suffering from severe brain hemorrhages and infections.
How similar studies have performed: While similar approaches have been explored, this specific method of Active Controlled Irrigation and Drainage is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years of age 2. Need of drainage for one of the following underlying conditions: Intraventricular hemorrhage, intracranial hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis 3. Indication for active treatment evaluated by treating physician for underlying conditions; Intraventricular hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis 4. Signed informed consent obtained by subject or Legally Authorized Representative Exclusion Criteria: 1. Subject has fixed and dilated pupils 2. Pregnant women 3. Presence of Moyamoya 4. History or presence of clotting disorder. 5. Platelet count less than 100,000, INR greater than 1.4
Where this trial is running
Columbus, Ohio
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Patrick Youssef, MD — Ohio State University
- Study coordinator: Edouard Beliaire
- Email: edouard.belizaire@osumc.edu
- Phone: 6143666936
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.