Introduction Intraventricular hemorrhage (IVH) is associated with elevated intracranial pressure, hydrocephalus, and poor outcomes. Standard external ventricular drainage (EVD) remains the mainstay of treatment but is limited by frequent occlusion and incomplete clot evacuation. IRRAflow is a dual‐lumen, self‐irrigating catheter designed to improve hematoma clearance and reduce device‐related complications through active cerebrospinal fluid exchange (ACE). The Deployment of an Irrigating Catheter System for Intraventricular Hemorrhage (DIVE) Trial is a prospective historical case control study evaluating the safety and efficacy of the IRRAflow catheter. We report interim results from the DIVE trial comparing ACE to standard EVD. Methods Ten patients underwent treatment of intraventricular hemorrhage with the irrigating catheter system and were enrolled between June 2022 and July 2024. A historical cohort of 60 consecutive patients with IVH treated with an external ventricular drain (EVD) between March 2018 and July 2020 was identified from a prospectively maintained intracranial hemorrhage quality assurance database. Outcomes included day 5 IVH volume, catheter duration, ICU and hospital length of stay (LOS), and device‐related serious adverse events. Hematoma volumes were segmented via 3D Slicer. Results The irrigating catheter system trended towards greater median clot volume reduction compared with EVD (‐50.7% IQR ‐76.9 to ‐23.6 vs ‐9.5% IQR ‐54.8 to 65.3; p=0.06). Median catheter duration trended towards shorter in‐dwelling time with the irrigating system (6.8 4.6‐9.9 vs 9.0 5.0‐11.0 days; p=0.15), while ICU and hospital length of stay were comparable between groups (12.5 vs 13.2 days, p=0.52; 28.6 vs 24.4 days, p=0.51). Notably, no device‑related serious adverse events occurred in the irrigating cohort, compared with 21 in the EVD group. Conclusions Active cerebrospinal fluid exchange using the IRRAflow catheter demonstrates promising results in hematoma volume reduction and catheter in‐dwelling time in this pilot cohort, with comparable ICU and hospital lengths of stay. The marked reduction in device‐related serious adverse events supports IRRAflow's safety profile and feasibility. These findings may serve as an initial effect size for planning an appropriately powered clinical trial. image
Mona Nasrallah (Sat,) studied this question.