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NCT05649904 · ClinicalTrials.gov registry record · NA
AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis
A NA study of Subarachnoid Hemorrhage and Intraventricular Hemorrhage, sponsored by Ohio State University.
- Recruiting
- Registry status
- NA
- Development phase
- 240
- Enrollment target
- 1
- Study location
NCT05649904 is a NA study of Subarachnoid Hemorrhage and Intraventricular Hemorrhage that is actively recruiting participants, run by Ohio State University. The registered enrollment target is 240 participants, below the 3,576-participant average among 21 other Subarachnoid Hemorrhage trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05649904, a NA study of Subarachnoid Hemorrhage and Intraventricular Hemorrhage, is actively recruiting participants, sponsored by Ohio State University.
- RECRUITING
- Registry status
- NA
- Development phase
- 240 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DEVICE IRRAflow with Active Fluid Exchange System
- DEVICE External Ventricular Drain
Study Locations (1)
Ohio
- The Ohio State University Wexner Medical Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2023-02-07 |
| Est. Completion | 2026-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05649904
The ClinicalTrials.gov registry entry for NCT05649904 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,576-participant average among 21 other Subarachnoid Hemorrhage trials with a reported enrollment target (93% lower). The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Subarachnoid Hemorrhage appearing as the primary indexed condition, and to 2 interventions - of which IRRAflow with Active Fluid Exchange System is the first listed.
NCT05649904 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT05649904 about?
NCT05649904 is a clinical study titled "AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis". 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 (...
What is the current status of trial NCT05649904?
This trial is currently recruiting. It is a NA study. The enrollment target is 240 participants. The study started on 2023-02-07. Estimated completion is 2026-01.
What conditions does trial NCT05649904 study?
This clinical trial studies the following conditions: Subarachnoid Hemorrhage, Intraventricular Hemorrhage, Ventriculitis, Subdural Hematoma.
What interventions are being tested in trial NCT05649904?
The interventions under investigation include: IRRAflow with Active Fluid Exchange System (DEVICE), External Ventricular Drain (DEVICE).
Who is sponsoring clinical trial NCT05649904?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05649904 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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