NCT05649904 AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis
| NCT ID | NCT05649904 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ohio State University |
| Condition | Intraventricular Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2023-02-07 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2023-02-07 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Patrick Youssef, MD
PRINCIPAL INVESTIGATOR
Ohio State University
Frequently Asked Questions
Who can join the NCT05649904 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intraventricular Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05649904 currently recruiting?
Yes, NCT05649904 is actively recruiting participants. Contact the research team at edouard.belizaire@osumc.edu for enrollment information.
Where is the NCT05649904 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT05649904 clinical trial?
NCT05649904 is sponsored by Ohio State University. The principal investigator is Patrick Youssef, MD at Ohio State University. The trial plans to enroll 240 participants.