Trials / Recruiting
RecruitingNCT05649904
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- Sponsor
- Ohio State University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | IRRAflow with Active Fluid Exchange System | IRRAflow® Active Fluid Exchange System is an intracranial drainage system intended for use by professional medical hospital personnel, trained and experienced in neurosurgical medical care. The intracranial pressure is kept at a safe level by draining excessive intracranial fluid. The system incorporates an irrigation support mechanism, used to irrigate the system in a controlled, programmed manner to minimize catheter occlusion. Additionally, a manual bolus can be given to facilitate keeping the catheter clear of occlusion or to clear the catheter of occlusion if one is present. This mechanism works by producing a bolus pulse using short periods of high flow (i.e. flow pulses). |
| DEVICE | External Ventricular Drain | The External Ventricular Drain (EVD) is used standard of care at the study site for ventricular drainage. |
Timeline
- Start date
- 2023-02-07
- Primary completion
- 2026-01-01
- Completion
- 2026-01-01
- First posted
- 2022-12-14
- Last updated
- 2025-04-01
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05649904. Inclusion in this directory is not an endorsement.