IRRAflow Drainage for Brain Hemorrhage

(AFFECT Trial)

Overseen By Edouard Beliaire

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Pregnancy, Moyamoya, Clotting disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Duration not specified

240 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new device called IRRAflow, which actively cleans out fluid, blood, and bacteria from certain areas in the brain. It targets patients with brain bleeding or infections. The device works by flushing out harmful substances to keep the brain areas clean and reduce complications.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment IRRAflow Drainage for Brain Hemorrhage?

The research indicates that while external ventricular drain (EVD) is a standard treatment for intraventricular hemorrhage (IVH), neuroendoscopic (NE) evacuation, which is a similar approach to IRRAflow, has shown a reduced risk of needing a ventriculoperitoneal (VP) shunt compared to EVD. This suggests that active controlled irrigation and drainage, like IRRAflow, may offer benefits in managing brain hemorrhages. ^{1 2 3 4 5}

Is the IRRAflow system generally safe for use in humans?

The IRRAflow system, used for brain conditions, is generally considered safe, but there are risks of bleeding and infection, similar to other external ventricular drainage systems. Studies show bleeding complications can occur in 10% to 44% of cases, and infections are a concern, though specific rates vary. ^{6 7 8 9 10}

How does the IRRAflow treatment for brain hemorrhage differ from other treatments?

The IRRAflow treatment is unique because it uses a self-irrigating catheter system that continuously flushes and drains the brain's ventricles, helping to remove toxic substances and blood clots more effectively than traditional external ventricular drains, which often require frequent manual flushing and replacement. ^{9 11 12 13 14}

Research Team

Patrick Youssef

Principal Investigator

Ohio State University

Eligibility Criteria

Adults over 18 needing drainage for brain conditions like intraventricular hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma, or ventriculitis can join. They must need active treatment and give informed consent. Those with fixed dilated pupils, Moyamoya disease, clotting disorders, pregnancy, low platelets or high INR can't participate.

Inclusion Criteria

Signed informed consent obtained by subject or Legally Authorized Representative

My doctor says I need treatment for a brain bleed or infection.

I need a procedure to remove excess fluid due to bleeding or infection in my brain.

Exclusion Criteria

Your blood does not clot normally, and you have very low platelet count.

My pupils are fixed and do not respond to light.

I have been diagnosed with Moyamoya disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects are randomized to receive either the IRRAflow device or EVD device for intracranial pressure monitoring and fluid drainage

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• External Ventricular Drain
• IRRAflow

Trial Overview The study compares two methods of draining harmful fluids from the brain: IRRAflow (an active system) versus a standard passive drain (EVD). Participants are randomly chosen to receive one method and monitored for a month to see which is safer and more effective.

Participant Groups

Group I: IRRAflow with Active Fluid Exchange System (IRRAflow) Experimental Treatment 1 Intervention

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.

Group II: External Ventricular Drainage (EVD) Active Control 1 Intervention

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.

External Ventricular Drain is already approved in European Union, United States for the following indications:

Approved in European Union as External Ventricular Drainage for:

• Intraventricular hemorrhage
• Subarachnoid hemorrhage
• Subdural hematoma
• Ventriculitis

Approved in United States as External Ventricular Drainage for:

• Intraventricular hemorrhage
• Subarachnoid hemorrhage
• Subdural hematoma
• Ventriculitis

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

IRRAS

Industry Sponsor

Trials

5

Recruited

730+

Findings from Research

The implantable cardioverter defibrillator (ICD) has proven to be more effective than traditional anti-arrhythmic therapies in reducing overall and cardiac mortality in patients at high risk for life-threatening arrhythmias, based on several randomized trials.

Recent advancements in ICD technology allow for more accurate detection of dangerous heart rhythms and offer various therapy options, including painless pacing and low-energy cardioversion, making the implantation process simpler and more efficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The implantable cardioverter defibrillator: technology, indications, and impact on cardiovascular survival. Bhatia, A., Cooley, R., Berger, M., et al.[2004]

Bridging patients with a temporary dual-coil ICD lead and external ICD after the extraction of a cardiac implantable electronic device (CIED) due to endovascular infection is a feasible management strategy.

This approach allows patients to maintain protection against life-threatening ventricular tachyarrhythmias while addressing the infection, highlighting its potential clinical benefits compared to other management options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporary external implantable cardioverter-defibrillator as a bridge to reimplantation after infected device extraction. Dębski, M., Ząbek, A., Boczar, K., et al.[2020]

In a study of 115 heart failure patients, upgrading from an implantable cardioverter-defibrillator (ICD) to a cardiac resynchronization therapy defibrillator (CRT-D) showed a trend towards reduced ventricular arrhythmias (VA) in patients who responded positively to CRT, with a decrease from 0.51 to 0.30 episodes per year.

Conversely, patients who did not respond to CRT experienced a significant increase in VA episodes requiring device therapy, rising from 0.40 to 1.21 episodes per year, highlighting the importance of patient response to CRT in managing arrhythmia risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implantable cardioverter-defibrillator patients who are upgraded and respond to cardiac resynchronization therapy have less ventricular arrhythmias compared with nonresponders. Thijssen, J., Borleffs, CJ., Delgado, V., et al.[2011]

A systematic review and meta-analysis of 303 patients with intraventricular hemorrhage (IVH) found that patients treated with external ventricular drain (EVD) had a significantly higher risk of requiring a ventriculoperitoneal (VP) shunt compared to those treated with neuroendoscopic (NE) evacuation, with a relative risk of 1.93.

Despite the treatment method, the overall prognosis for patients with IVH remains poor, highlighting the need for large randomized controlled trials to better understand the benefits and outcomes of NE compared to EVD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic Evacuation of Massive Intraventricular Hemorrhages Reduces Shunt Dependency: A Meta-Analysis. Fiorindi, A., Saraceno, G., Zanin, L., et al.[2022]

Implantable cardioverter-defibrillators (ICDs) are highly effective in preventing sudden cardiac death from dangerous heart rhythms, with modern devices offering reliable detection and treatment options, including pain-free therapies.

While traditional transvenous ICDs are the most common due to their proven benefits and low risks, alternative configurations like subcutaneous ICDs and other extravascular approaches are being developed to address complications such as lead placement issues and infections, allowing for more personalized treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-traditional implantable cardioverter-defibrillator configurations and insertion techniques: a review of contemporary options. Tonko, JB., Rinaldi, CA.[2022]

In a study of 155 acute brain-injured patients, EVD insertion was found to cause small hemorrhages and edema around the catheter, but these changes did not lead to neurological deterioration or increased intracranial pressure.

The average volume of hemorrhagic lesions increased from 8.16 ml to 15 ml over time, and factors like hypertension and multiple insertions were linked to a higher incidence of these hemorrhages, indicating a need for careful monitoring in at-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External ventricular drain causes brain tissue damage: an imaging study. Ortolano, F., Carbonara, M., Stanco, A., et al.[2018]

In the CLEAR III trial involving 250 patients with external ventricular drainage (EVD), the rates of new bleeding and symptomatic hemorrhages were low, with only 16.8% experiencing any new bleeds and just 2.4% suffering symptomatic hemorrhages.

The incidence of bacterial meningitis or ventriculitis was also low at 4.4%, indicating that the risks of bleeding and infection associated with EVD in this trial are comparable to those reported in previous studies, despite the complexity of the treatment involving thrombolysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bleeding and infection with external ventricular drainage: a systematic review in comparison with adjudicated adverse events in the ongoing Clot Lysis Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR-III IHV) trial. Dey, M., Stadnik, A., Riad, F., et al.[2023]

The incidence of catheter-induced hemorrhage (CIH) after external ventricular drain (EVD) placement decreased from 33% to 17.7% following the implementation of platelet inhibition assays, indicating improved outcomes in this patient population.

Despite the overall reduction in hemorrhage rates, the use of the VerifyNow assay and platelet transfusions did not significantly impact the risk of CIH, suggesting that other factors may contribute to hemorrhagic complications in patients on antiplatelet therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemorrhagic Complications of External Ventriculostomy in the Aspirin and P2Y12 Response Assay Era. Majmundar, N., Sarris, C., Shastri, D., et al.[2019]

The IRRAflow® system, used for continuous irrigation and drainage of the cerebral ventricles, showed marked improvement in three patients with cerebral ventriculitis, indicating its efficacy in managing this life-threatening condition.

This system may also be beneficial for treating other brain injuries, such as intraventricular hemorrhage and intracranial abscesses, suggesting its versatility in neuro-intensive care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of cerebral ventriculitis with a new self-irrigating catheter system: narrative review and case series. Stati, G., Migliorino, E., Moneti, M., et al.[2023]

A risk model for external ventricular drainage (EVD)-related infections was developed using data from 439 patients, identifying key risk factors such as diabetes and drainage duration, with an overall infection rate of 17.1%.

The model demonstrated good predictive ability with an AUC of 0.758 during internal validation and 0.720 during external validation, and is available as a user-friendly online calculator to assist clinicians in assessing infection risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Construction and validation of infection risk model for patients with external ventricular drainage: a multicenter retrospective study. Wang, P., Luo, S., Cheng, S., et al.[2023]

Intraventricular hemorrhage (IVH) is a serious condition that can lead to significant health issues, and patients often require external ventricular drains to manage the complications, which can frequently become clogged.

The case presented demonstrates the use of drainage, irrigation, and fibrinolytic therapy (DRIFT) with the IRRAflow® catheter as an effective treatment for severe IVH, potentially improving patient outcomes compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drainage, Irrigation, and Fibrinolytic Therapy (DRIFT) for Adult Intraventricular Hemorrhage Using IRRAflow® Self-Irrigating Catheter. Rajjoub, K., Hess, RM., O'Connor, TE., et al.[2023]

The IRRAflow system combined with alteplase (tPA) effectively cleared intraventricular hemorrhage (IVH) in three patients with primary hypertensive ganglionic hemorrhages, allowing for drain removal within 8 days without any complications.

Compared to historical data from 28 patients treated with standard external ventricular drainage (EVD), the IRRAflow system significantly reduced the duration of EVD treatment and the need for drain replacements, indicating improved efficacy and safety in managing IVH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drainage, Irrigation, and Fibrinolytic Therapy (DRIFT) for Adult Intraventricular Hemorrhage Associated with Primary Hypertensive Hemorrhages Using IRRAflow Self-Irrigating Catheter: A Report of Three Cases and Prior Historical Controls. Field, NC., Custozzo, AJ., Harland, TA., et al.[2023]

Bilateral external ventricular drains (EVDs) significantly reduce intraventricular hemorrhage (IVH) volume more effectively than single EVDs, with a notable percentage change observed after 5 days (p = 0.0034).

Factors influencing IVH volume reduction include patient age and the duration of EVD placement, with older patients and longer drainage times associated with greater reductions in IVH volume.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Reduction of Intraventricular Hemorrhage Volume: Single- Versus Dual-Catheter Drainage. Hussain, SS., Raza, A., Shahid, S., et al.[2019]

In a study of 130 patients undergoing external ventricular drainage (EVD) for conditions like subarachnoid hemorrhage and intracerebral hemorrhage, 27.6% developed infections related to the procedure, highlighting the importance of monitoring and minimizing the duration of EVD use.

The overall mortality rate was 46.9%, with significantly higher mortality observed in patients with lower Glasgow Coma Scores (GCS) at the time of EVD insertion, indicating that EVD should be used cautiously and only when absolutely necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of external ventricular drainage in the management of intraventricular hemorrhage; its complications and management. Kirmani, AR., Sarmast, AH., Bhat, AR.[2020]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

The implantable cardioverter defibrillator: technology, indications, and impact on cardiovascular survival. [2004]

2. Japan pubmed.ncbi.nlm.nih.gov

Temporary external implantable cardioverter-defibrillator as a bridge to reimplantation after infected device extraction. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Implantable cardioverter-defibrillator patients who are upgraded and respond to cardiac resynchronization therapy have less ventricular arrhythmias compared with nonresponders. [2011]

4. India pubmed.ncbi.nlm.nih.gov

Endoscopic Evacuation of Massive Intraventricular Hemorrhages Reduces Shunt Dependency: A Meta-Analysis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Non-traditional implantable cardioverter-defibrillator configurations and insertion techniques: a review of contemporary options. [2022]

6. Austria pubmed.ncbi.nlm.nih.gov

External ventricular drain causes brain tissue damage: an imaging study. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Bleeding and infection with external ventricular drainage: a systematic review in comparison with adjudicated adverse events in the ongoing Clot Lysis Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR-III IHV) trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Hemorrhagic Complications of External Ventriculostomy in the Aspirin and P2Y12 Response Assay Era. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Treatment of cerebral ventriculitis with a new self-irrigating catheter system: narrative review and case series. [2023]

10. Austria pubmed.ncbi.nlm.nih.gov

Construction and validation of infection risk model for patients with external ventricular drainage: a multicenter retrospective study. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Drainage, Irrigation, and Fibrinolytic Therapy (DRIFT) for Adult Intraventricular Hemorrhage Using IRRAflow® Self-Irrigating Catheter. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Drainage, Irrigation, and Fibrinolytic Therapy (DRIFT) for Adult Intraventricular Hemorrhage Associated with Primary Hypertensive Hemorrhages Using IRRAflow Self-Irrigating Catheter: A Report of Three Cases and Prior Historical Controls. [2023]

13. Germany pubmed.ncbi.nlm.nih.gov

Postoperative Reduction of Intraventricular Hemorrhage Volume: Single- Versus Dual-Catheter Drainage. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Role of external ventricular drainage in the management of intraventricular hemorrhage; its complications and management. [2020]