Clinical trial NCT05649904: AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis
Official title: Use of Active Fluid Exchange to Therapeutically Treat Intracranial Bleeding and Infection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intraventricular Hemorrhage
Subarachnoid Hemorrhage
Subdural Hematoma
Ventriculitis
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: IRRAS
First posted: 2022-12-14
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of revision procedures for the IRRAflow and EVD/Drainage catheters
timeFrame: Immediately post-procedure
Secondary outcomes:
measure: Time to clearance of blood or bacterial mass as measured by head CT scan
timeFrame: Immediately post-procedure
measure: Rate of catheter-related infection
timeFrame: Immediately post-procedure
measure: Length of ICU stay
timeFrame: Baseline
measure: Rate of shunt dependency
timeFrame: Immediately post-procedure
measure: Indwell time of EVD/Drainage and IRRAflow Catheter
timeFrame: Immediately post-procedure
measure: Functional Status - at inclusion and 30 days
timeFrame: 30 days post subject discharge
measure: Mortality rates - intraprocedural and at 30 days
timeFrame: 30 days post subject discharge
measure: Functional Status - at inclusion and 30 days
timeFrame: 30 days post subject discharge
measure: Functional Status - at inclusion and 30 days
timeFrame: 30 days post subject discharge
measure: Functional Status - at inclusion and 30 days
timeFrame: 30 days post subject discharge
measure: Functional Status - at inclusion and 30 days
timeFrame: 30 days post subject discharge
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Patrick Youssef, MD
role: PRINCIPAL_INVESTIGATOR
References: