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| Name | Class |
|---|---|
| IRRAS | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IRRAflow with Active Fluid Exchange System (IRRAflow) | Experimental | Subjects may be randomized to receive the IRRAflow with Active Fluid Exchange System (intervention) for intracranial pressure monitoring and for externally draining intracranial fluid as a means of reducing intracranial pressure. |
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| External Ventricular Drainage (EVD) | Active Comparator | Subjects may be randomized to receive an External Ventricular Drain (control) for intracranial pressure monitoring and for externally draining intracranial fluid as a means of reducing intracranial pressure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IRRAflow with Active Fluid Exchange System | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of revision procedures for the IRRAflow and EVD/Drainage catheters | Immediately post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Time to clearance of blood or bacterial mass as measured by head CT scan | Immediately post-procedure | |
| Rate of catheter-related infection | Immediately post-procedure | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edouard Beliaire | Contact | 6143666936 | edouard.belizaire@osumc.edu | |
| Patrick Youssef, MD | Contact | 6143666590 | patrick.youssef@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Patrick Youssef, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Wexner Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| External Ventricular Drain | Device | The External Ventricular Drain (EVD) is used standard of care at the study site for ventricular drainage. |
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| Length of ICU stay |
| Baseline |
| Rate of shunt dependency | Immediately post-procedure |
| Indwell time of EVD/Drainage and IRRAflow Catheter | Immediately post-procedure |
| 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 |
| Mortality rates - intraprocedural and at 30 days | 30 days post subject discharge |
| 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 |
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| D006408 | Hematoma, Subdural |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D006406 | Hematoma |
| D014947 | Wounds and Injuries |
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