Intraventricular HemorrhageAFFECTNCT05649904
AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis
A study testing IRRAflow with Active Fluid Exchange System and External Ventricular Drain in people with Intraventricular Hemorrhage and Subarachnoid Hemorrhage, run by Ohio State University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma
- What is being tested?
- IRRAflow with Active Fluid Exchange System and External Ventricular Drain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2023to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years of age
- Need of drainage for one of the following underlying conditions: Intraventricular hemorrhage, intracranial hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis
- Indication for active treatment evaluated by treating physician for underlying conditions; Intraventricular hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis
- Signed informed consent obtained by subject or Legally Authorized Representative
Who cannot join
- Subject has fixed and dilated pupils
- Pregnant women
- Presence of Moyamoya
- History or presence of clotting disorder.
- Platelet count less than 100,000, INR greater than 1.4
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Edouard Belizaire, edouard.belizaire@osumc.edu
Uchechi Okafor, Uchechi.Okafor@osumc.edu
About this study
Official title: Use of Active Fluid Exchange to Therapeutically Treat Intracranial Bleeding and Infection
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.
- Being tested
- IRRAflow with Active Fluid Exchange System, External Ventricular Drain
- Medical subject headings
- Subarachnoid Hemorrhage, Hematoma, Subdural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRRAflow with Active Fluid Exchange SystemDevice
Also called IRRAflow
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 DrainDevice
Also called EVD
The External Ventricular Drain (EVD) is used standard of care at the study site for ventricular drainage.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: IRRAflow with Active Fluid Exchange System |
| 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. Receives: Device: External Ventricular Drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of revision procedures for the IRRAflow and EVD/Drainage catheters
Measured: Immediately post-procedure
Secondary outcomes (11)
Time to clearance of blood or bacterial mass as measured by head CT scan
Measured: Immediately post-procedure
Rate of catheter-related infection
Measured: Immediately post-procedure
Length of ICU stay
Measured: Baseline
Rate of shunt dependency
Measured: Immediately post-procedure
Indwell time of EVD/Drainage and IRRAflow Catheter
Measured: 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).
Measured: 30 days post subject discharge
Mortality rates - intraprocedural and at 30 days
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 30 days post subject discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start7 Feb 2023
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraventricular HemorrhageStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- IRRAS
- Responsible party
- Principal investigator, Patrick Youssef, Ohio State University
- Investigators
- Patrick Youssef, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649904
- Sponsor's protocol ID
- 2022H0197
- Acronym
- AFFECT
- Status last verified
- Mar 2025
- First submitted
- 24 Oct 2022
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Active Fluid Exchange to Therapeutically Treat Intracranial Bleeding and Infection
- ClinicalTrials.gov ID
- NCT05649904
- Acronym / sponsor ID
- AFFECT / 2022H0197
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- IRRAS
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IRRAflow with Active Fluid Exchange System (IRRAflow) | Experimental | Device: IRRAflow with Active Fluid Exchange SystemSubjects 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. |
| External Ventricular Drainage (EVD) | Active comparator | Device: External Ventricular DrainSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years of age
- Need of drainage for one of the following underlying conditions: Intraventricular hemorrhage, intracranial hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis
- Indication for active treatment evaluated by treating physician for underlying conditions; Intraventricular hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis
- Signed informed consent obtained by subject or Legally Authorized Representative
Key exclusion criteria (5 listed)
- Subject has fixed and dilated pupils
- Pregnant women
- Presence of Moyamoya
- History or presence of clotting disorder.
- Platelet count less than 100,000, INR greater than 1.4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRRAflow with Active Fluid Exchange SystemAlso: IRRAflowIRRAflow® 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). | Device | IRRAflow with Active Fluid Exchange System (IRRAflow) |
| External Ventricular DrainAlso: EVDThe External Ventricular Drain (EVD) is used standard of care at the study site for ventricular drainage. | Device | External Ventricular Drainage (EVD) |
Primary outcome
Rate of revision procedures for the IRRAflow and EVD/Drainage catheters
Time frame: Immediately post-procedure
11 secondary outcomes
Time to clearance of blood or bacterial mass as measured by head CT scan
Time frame: Immediately post-procedure
Rate of catheter-related infection
Time frame: Immediately post-procedure
Length of ICU stay
Time frame: Baseline
Rate of shunt dependency
Time frame: Immediately post-procedure
Indwell time of EVD/Drainage and IRRAflow Catheter
Time frame: Immediately post-procedure
Functional Status - at inclusion and 30 days
Time frame: 30 days post subject discharge
Mortality rates - intraprocedural and at 30 days
Time frame: 30 days post subject discharge
Functional Status - at inclusion and 30 days
Time frame: 30 days post subject discharge
Functional Status - at inclusion and 30 days
Time frame: 30 days post subject discharge
Functional Status - at inclusion and 30 days
Time frame: 30 days post subject discharge
Functional Status - at inclusion and 30 days
Time frame: 30 days post subject discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Youssef, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IRRAflow with Active Fluid Exchange System and External Ventricular Drain in people with Intraventricular Hemorrhage and Subarachnoid Hemorrhage, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edouard Beliaire (6143666936, edouard.belizaire@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of revision procedures for the IRRAflow and EVD/Drainage catheters (time frame: Immediately post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.