AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis

Launched by OHIO STATE UNIVERSITY · Dec 5, 2022

Keywords

ClinConnect Summary

The AFFECT Study is a clinical trial designed to explore how effective and safe a new treatment called Active Controlled Irrigation and Drainage (IRRAflow) is for patients with certain brain conditions, such as bleeding in the brain (intraventricular hemorrhage, subarachnoid hemorrhage, and subdural hematoma) and infections (ventriculitis). This study will compare the IRRAflow device with a standard treatment known as Passive External Ventricular Drainage (EVD). Participants will be randomly assigned to one of these two treatments and will be monitored for one month after the procedure to see how well they recover.

To be eligible for this trial, participants must be at least 18 years old and require treatment for one of the specified conditions. They should also be able to provide informed consent, either themselves or through a legally authorized representative. However, individuals with certain medical issues, such as fixed dilated pupils, pregnancy, specific blood disorders, or a very low platelet count, will not be able to participate. Overall, this study aims to improve treatment options for serious brain conditions by evaluating the new IRRAflow device's effectiveness compared to the standard approach.

Gender

ALL

Eligibility 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

Trial Officials