Study protocol for ACTIVE study: safety and feasibility evaluation of external ventricular drainage with ACTIVE fluid exchange in intraventricular hemorrhage-a phase 2, multi-center, randomized controlled trial.

ABSTRACT:

Background

Primary intraventricular hemorrhage (IVH) or IVH secondary to intracerebral (ICH) and subarachnoid hemorrhage (SAH) are known to have a very poor prognosis, with an expected mortality between 50 and 80% (Hinson et al. Current Neurology and Neuroscience Reports 10:73-82, 2010). Clearance of IVH might improve patient outcome.

Methods

The study is designed as an investigator-initiated, comparative, prospective, multi-center, 1:1 randomized phase 2 trial evaluating the efficacy and safety of active irrigation in external ventricular drainage (intervention arm-IRRAflow) compared to passive external ventricular drainage (control arm-EVD). The trial will enroll 58 patients with primary or secondary IVH. Major eligibility criteria include age ≥18 years of age, IVH documen

SUBMITTER: Haldrup M 

PROVIDER: S-EPMC9798588 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature