Efficacy of Daily IV Administration of Dornase Alfa up to 14 Days Post Subarachnoid Hemorrhage on Functional Independence at 6 Months: a PROBE Multicenter Open-label Randomized Controlled Trial

What this Trial Is About

This research aims to evaluate the effect of daily intravenous infusion of dornase alfa on patients who have suffered a subarachnoid hemorrhage (SAH) due to aneurysm rupture. SAH often leads to high mortality and reduced quality of life among survivors, mainly due to delayed cerebral ischemia (DCI), a serious complication occurring mostly between days 4 and 14 after the hemorrhage. The trial explores how targeting neutrophil extracellular traps (NETs), which contribute to microvascular obstruction and inflammation, may influence functional independence at 6 months post-SAH. Participants will receive either a daily intravenous bolus of dornase alfa at a dose of 125 microg/kg up to day 14 following SAH, in addition to the usual care, or usual care alone. This is a randomized, open-label trial comparing the experimental treatment group to the control group receiving standard management. The study treatment focuses on reducing thrombo-inflammation to prevent DCI and improve outcomes. During the study, participants will be closely monitored for functional independence at 6 months, which is the primary outcome measure. Researchers will assess the effects of the treatment on neurological function and complications related to SAH. Safety monitoring will also be conducted, and participants' health status will be observed throughout the trial period. The total study duration extends to at least 6 months from treatment initiation, with detailed follow-up on patient recovery and independence.

Efficacy of Daily IV Administration of Dornase Alfa up to 14 Days Post Subarachnoid Hemorrhage on Functional Independence at 6 Months