Active Removal of IntraCerebral Hematoma Via Active Irrigation

Launched by IRRAS · Nov 3, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat bleeding in the brain, known as cerebral hemorrhage, by using a method called active irrigation with a device called IRRAflow®. The goal is to see if this method, combined with a medication called tPA, can help clear the blood faster compared to the traditional approach, which relies on passive drainage. This trial is currently looking for participants aged 18 and older who need a special type of treatment called an external ventricular drain (EVD) due to bleeding in the brain.

To be eligible, participants must have a certain size of bleeding and be able to receive medication daily for three days. However, those with certain conditions, such as severe blood clotting issues or specific brain problems, cannot participate. If you join the trial, you will receive careful monitoring and treatment to see how well this new approach works. Your involvement could help advance treatment options for others facing similar challenges in the future.

Gender

ALL

Eligibility 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