Using a new catheter system to treat intraventricular hemorrhage
DIVE: Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage
This study is testing a new catheter system to see if it can safely and effectively drain fluid in the brains of patients with intraventricular hemorrhage, compared to standard catheters.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 17 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05970549 on ClinicalTrials.gov |
What this trial studies
This research evaluates the safety and effectiveness of the IRRAflow® System catheters for draining intracranial fluid in patients with intraventricular hemorrhage (IVH). The study compares the IRRAflow® system to standard catheters used for the same purpose, focusing on reducing intracranial pressure. The study involves monitoring various parameters such as intracranial pressure and cerebral perfusion pressure to optimize patient outcomes. Participants will be treated within 72 hours of their condition onset, and informed consent will be obtained from them or their legal representatives.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with documented intraventricular hemorrhage requiring cerebrospinal fluid drainage.
Not a fit: Patients with fixed and dilated pupils or those who are pregnant or nursing may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of intracranial pressure in patients with IVH, potentially reducing morbidity and mortality.
How similar studies have performed: While the IRRAflow® system is FDA approved, the specific application in this study is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>=18 years of age * Intraventricular hemorrhage documented on head CT or MRI scan * Need of cerebrospinal fluid drainage * Indication for active treatment evaluated by the treating physicians * Signed informed consent obtained by patient or Legal Authorized Representative * Treatment possible within 72 hours of ictus Exclusion Criteria: * Patient has fixed and dilated pupils * Pregnant or nursing women (fertile female participants will be required to take a validated pregnancy test for evaluation of pregnancy)
Where this trial is running
New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Christopher P Kellner, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Emily Svendsen
- Email: Emily.Svendsen@mountsinai.org
- Phone: (212) 241-3238
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.