| Title: |
Safety, harm, and efficacy of IRRAflow® versus external ventricular drainage for intraventricular hemorrhage: A randomized clinical trial |
| Authors: |
Jensen, Mette Haldrup; Rasmussen, Mads; Mohamad, Niwar; Dyrskog, Stig Eric; Thorup, Line; Mikic, Nikola; Wismann, Joakim; Grønhøj, Mads Hjortdal; Rom Poulsen, Frantz; Nazari, Mojtaba; Rehman, Naveed Ur; Simonsen, Claus Ziegler; Korshoej, Anders Rosendal |
| Source: |
Jensen, M H, Rasmussen, M, Mohamad, N, Dyrskog, S E, Thorup, L, Mikic, N, Wismann, J, Grønhøj, M H, Rom Poulsen, F, Nazari, M, Rehman, N U, Simonsen, C Z & Korshoej, A R 2023 'Safety, harm, and efficacy of IRRAflow® versus external ventricular drainage for intraventricular hemorrhage: A randomized clinical trial' medRxiv. https://doi.org/10.1101/2023.07.08.23292286 |
| Publisher Information: |
medRxiv |
| Publication Year: |
2023 |
| Collection: |
Aarhus University: Research |
| Description: |
Importance: Intraventricular hemorrhage (IVH) is associated with high morbidity and mortality. A strong need exists for treatment advances. IRRAflow® was recently introduced as a method for minimally invasive, controlled, and accelerated IVH wash-out. However, no current evidence supports this technology. Here, we present the first pivotal safety/efficacy evaluation in a randomized controlled setting. Objective: To evaluate the safety and efficacy of active hematoma irrigation using the IRRAflow® device compared with standard external ventricular drainage (EVD) for the IVH treatment. Design, setting, and participants: This investigator-initiated, prospective multi-center, 1:1 randomized, single-blinded, clinical trial was conducted at the Aarhus University Hospital and Odense University Hospital in Denmark from January 13, 2022 to November 24, 2022. The trial was set to include 58 IVH patients with prespecified interim analysis at final endpoint collection for the first 20 patients. Interventions: Patients were randomized to receive either IRRAflow® or standard EVD treatment. The IRRAflow® performs periodic active irrigation and aspiration contrary to standard passive gravity-driven EVD. Main outcomes and measures: Outcomes were chosen to reflect key IRRAflow® value propositions. The primary outcome was rate of catheter occlusions. The main outcome of the prespecified interim analysis was risk of severe adverse events (SAEs). Secondary outcomes were hematoma clearance rate, shunt dependency rate, procedure time for primary catheter placement, length of intensive care unit (ICU) stay, treatment duration, functional outcome (modified Rankin Scale (mRS) and extended Glasgow Outcome Scale (eGOS)) 90 days after inclusion, adverse events (AEs) (including catheter-related infections and procedure-related complications), and overall survival. Results: The study was terminated early due to a significantly increased risk of SAEs in the IRRAflow® group compared with EVD (risk difference = 0.43, 95% confidence interval (CI) ... |
| Document Type: |
report |
| Language: |
English |
| DOI: |
10.1101/2023.07.08.23292286 |
| Availability: |
https://pure.au.dk/portal/en/publications/832902dd-7576-430e-9728-080a6baa65b9; https://doi.org/10.1101/2023.07.08.23292286 |
| Rights: |
info:eu-repo/semantics/openAccess ; http://creativecommons.org/licenses/by-nd/4.0/ |
| Accession Number: |
edsbas.29CD44D8 |
| Database: |
BASE |