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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT05649904
Status
Recruiting
Apply to this trial

Conditions

  • Intraventricular Hemorrhage
  • Subarachnoid Hemorrhage
  • Subdural Hematoma
  • Ventriculitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IRRAflow with Active Fluid Exchange System — DEVICE
    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).
  • External Ventricular Drain — DEVICE
    The External Ventricular Drain (EVD) is used standard of care at the study site for ventricular drainage.

Study Details

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.

Key Dates

Start date
Feb 7, 2023
Status verified
Mar 2025
Primary completion
Jan 31, 2026
Completion
Jan 31, 2026

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IRRAflow with Active Fluid Exchange System (IRRAflow)
    Subjects may be randomized to receive the IRRAflow with Active Fluid Exchange System (intervention) for intracranial pressure monitoring and for externally draining intracranial fluid as a means of reducing intracranial pressure.
  • Active Comparator: External Ventricular Drainage (EVD)
    Subjects may be randomized to receive an External Ventricular Drain (control) for intracranial pressure monitoring and for externally draining intracranial fluid as a means of reducing intracranial pressure.

Primary Outcome Measure

Rate of revision procedures for the IRRAflow and EVD/Drainage catheters [ Time Frame: Immediately post-procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State University Wexner Medical CenterColumbusOhio43210
Edouard Belizaire
[email protected]
Uchechi Okafor
[email protected]
Patrick Youssef (PRINCIPAL_INVESTIGATOR)
Shahid Nimjee (SUB_INVESTIGATOR)
Ciaran Powers (SUB_INVESTIGATOR)

Find similar trials in Columbus, OH

By research site
The Ohio State University Wexner Medical Center· Columbus, OH

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