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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05649904
Other study ID # 2022H0197
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 7, 2023
Est. completion date January 2026

Study information

Verified date April 2023
Source Ohio State University
Contact Victoria Adams
Phone 6146854484
Email victoria.adams@osumc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date January 2026
Est. primary completion date January 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

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

Locations

Country Name City State
United States The Ohio State University Wexner Medical Center Columbus Ohio

Sponsors (2)

Lead Sponsor Collaborator
Ohio State University IRRAS

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of revision procedures for the IRRAflow and EVD/Drainage catheters Immediately post-procedure
Secondary Time to clearance of blood or bacterial mass as measured by head CT scan Immediately post-procedure
Secondary Rate of catheter-related infection Immediately post-procedure
Secondary Length of ICU stay Baseline
Secondary Rate of shunt dependency Immediately post-procedure
Secondary Indwell time of EVD/Drainage and IRRAflow Catheter Immediately post-procedure
Secondary Functional Status - at inclusion and 30 days The Modified Rankin Scale will be used to assess functional status. The Modified Rankin Scale ranges from 0 (no disability) to 6 (death). 30 days post subject discharge
Secondary Mortality rates - intraprocedural and at 30 days 30 days post subject discharge
Secondary Functional Status - at inclusion and 30 days The Extended Glasgow Coma Scale will be used to assess functional status. Results range from 1 (death) to 8 (upper good recovery). 30 days post subject discharge
Secondary Functional Status - at inclusion and 30 days The Barthel Index will be used to assess functional status. Scores for this assessment tool range from 0 - 100, with a higher number indicating a better functional status. 30 days post subject discharge
Secondary Functional Status - at inclusion and 30 days The Stroke Impact Scale will be used to assess functional status. Scores for this scale range from 0 - 100, with a higher number indicating a better functional status. 30 days post subject discharge
Secondary Functional Status - at inclusion and 30 days The EQ-VAS will be used to assess functional status. Participants rate their health from 0 (worst imaginable health) to 100 (best imaginable health). 30 days post subject discharge
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