Recruiting

Observational Study

Sponsor:

Ohio State University

Code:

NCT05649904

Conditions

Intraventricular Hemorrhage

Subarachnoid Hemorrhage

Subdural Hematoma

Ventriculitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IRRAflow with Active Fluid Exchange System

External Ventricular Drain

Study Details

Brief 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

Intraventricular Hemorrhage

Subarachnoid Hemorrhage

Subdural Hematoma

Ventriculitis

Study ID

NCT05649904

Start date

Feb 7, 2023

Status verified date

Mar, 2025

Completion date

Jan, 2026

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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).

External Ventricular Drain

The External Ventricular Drain (EVD) is used standard of care at the study site for ventricular drainage.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Edouard Beliaire

6143666936edouard.belizaire@osumc.edu

Patrick Youssef, MD

6143666590patrick.youssef@osumc.edu

Locations

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Edouard Belizaire

edouard.belizaire@osumc.edu

Uchechi Okafor

Uchechi.Okafor@osumc.edu

Principal Investigator:

Patrick Youssef

More Information

Sponsor

Ohio State University

Last update posted

Apr 1, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2025-04-01.