Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, Ventriculitis
Conditions
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.
Interventions
DEVICEIRRAflow 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).
The External Ventricular Drain (EVD) is used standard of care at the study site for ventricular drainage.
Sponsors
IRRAS
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of revision procedures for the IRRAflow and EVD/Drainage catheters | Immediately post-procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of catheter-related infection | Immediately post-procedure | — |
| Length of ICU stay | Baseline | — |
| Rate of shunt dependency | Immediately post-procedure | — |
| Time to clearance of blood or bacterial mass as measured by head CT scan | Immediately post-procedure | — |
| Functional Status - at inclusion and 30 days | 30 days post subject discharge | The Modified Rankin Scale will be used to assess functional status. The Modified Rankin Scale ranges from 0 (no disability) to 6 (death). |
| Mortality rates - intraprocedural and at 30 days | 30 days post subject discharge | — |
| Indwell time of EVD/Drainage and IRRAflow Catheter | Immediately post-procedure | — |
Countries
United States
Contacts
Primary ContactEdouard Beliaire
Backup ContactPatrick Youssef, MD
Outcome results
None listed