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

Purpose

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

  • Intraventricular Hemorrhage
  • Subarachnoid Hemorrhage
  • Subdural Hematoma
  • Ventriculitis

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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).
    Other names:
    • IRRAflow
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.
  • Device: External Ventricular Drain
    The External Ventricular Drain (EVD) is used standard of care at the study site for ventricular drainage.
    Other names:
    • EVD

Recruiting Locations

The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
Contact:
Edouard Belizaire
edouard.belizaire@osumc.edu

More Details

NCT ID
NCT05649904
Status
Recruiting
Sponsor
Ohio State University

Study Contact

Edouard Beliaire
6143666936
edouard.belizaire@osumc.edu

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center