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AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis
Use of Active Fluid Exchange to Therapeutically Treat Intracranial Bleeding and Infection
Who can join
Ages 18 and older · All sexes
Full 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
About the study
The goal of this clinical trial is to evaluate efficacy and safety of evacuation of cerebrospinal fluid, blood, and harmful bacteria from the intraventricular, subdural and subarachnoid spaces by Active Controlled Irrigation and Drainage (IRRAflow) compared to Passive External Ventricular Drainage (EVD).
Subjects with intraventricular hemorrhage, subarachnoid hemorrhage, subdural bleeding, and ventriculitis will be randomized to receive the IRRAflow device or EVD device and followed for one month post-procedure to compare outcomes between the subject groups.
What is being tested
- IRRAflow with Active Fluid Exchange System (device)
- External Ventricular Drain (device)
Sponsor: Ohio State University · Participants: 240 · Started: Feb 7, 2023
Contact the study team
- Edouard Beliaire · Phone: 6143666936
- Patrick Youssef, MD · Phone: 6143666590
Official record on ClinicalTrials.gov — NCT05649904
Locations in the U.S.
| Ohio | The Ohio State University Wexner Medical Center, Columbus |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.