Active removal of brain hemorrhage using irrigation
Active Removal of IntraCerebral Hematoma Via Active Irrigation of the Ventricular System
NA · IRRAS · NCT05118997
This study is testing if a new method using the IRRAflow® system can help clear brain bleeding faster and improve recovery for patients with spontaneous intracerebral hemorrhage compared to standard treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRRAS (industry) |
| Locations | 1 site (Helsinki) |
| Trial ID | NCT05118997 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of active irrigation using the IRRAflow® system combined with tPA infusion in clearing intracerebral and intraventricular hemorrhage compared to traditional passive drainage methods. It is a multicenter, randomized, controlled trial that aims to determine if this innovative approach can improve neurological outcomes for patients suffering from spontaneous intracerebral hemorrhage. The primary focus is on reducing the time required for hemorrhage clearance and assessing patient recovery through established neurological scales.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who require external ventricular drainage for spontaneous intracerebral hemorrhage.
Not a fit: Patients under 18 years old, those without a need for external ventricular drainage, or those with severe coagulopathy or fixed and dilated pupils may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to faster recovery and improved neurological outcomes for patients with brain hemorrhages.
How similar studies have performed: Other studies have explored similar interventions, but this specific approach using active irrigation with IRRAflow® is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \>18 years of age 2. Need of EVD 3. Active treatment 4. Signed informed consent obtained a. Based on institutional and country laws 5. Spontaneous ICH with maximum 30 square cm's 6. If needed, normal coagulation profile (PT, PTT, platelet count) 7. Treatment within 72 hours of ictus 8. Ability to administer 2.0 mg of tPA per day for 3 days Exclusion Criteria: 1. Age \< 18 years 2. No need of EVD 3. Patient has fixed and dilated pupils 4. Coagulopathy uncorrectable 5. Vascular pathology (e.g. Aneurysm involvement, AVM involvement) 6. Pregnant women
Where this trial is running
Helsinki
- Helsinki University — Helsinki, Finland (RECRUITING)
Study contacts
- Principal investigator: Behnam Rezai Jahromi, MD — University of Helsinki
- Study coordinator: John Unser, MBA
- Email: john.unser@irras.com
- Phone: 19712195984
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.
Conditions: Cerebral Hemorrhage, Intraventricular Hemorrhage, Hemorrhage