AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis
Recruiting · Not applicable · NCT05649904
Conditions: Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, Ventriculitis
At a glance
- Research payments reported, 2025
- $4,886
- U.S. investigators named
- 1
- Sites paid
- 1
- Planned or actual enrollment
- 240
About the trial
- Sponsor
- Ohio State University (with IRRAS)
- Tested
- IRRAflow with Active Fluid Exchange System (device), External Ventricular Drain (device)
- Dates
- Started 2023-02-07; completion 2026-01
- Results posted
- Not yet
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.
From ClinicalTrials.gov, last updated 2025-04-01. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Irras USA, Inc. reported $4,886 in research payments for this study in 2025 (6 payments).
Products named: Irraflow
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.