Evaluating a new method for draining fluid and blood in brain hemorrhages

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.