Futility Study of Deferoxamine Mesylate in Intracerebral Hemorrhage
Brief Description Of Study
This is a prospective, multi-center, double-blind, randomized, placebo-controlled, phase-II clinical trial. The total sample size required is 294 subjects with intracerebral hemorrhage (ICH). Subjects will be randomized in a 1:1 ratio to receive either deferoxamine mesylate (DFO) at 32 mg/kg/day (up to a maximum daily dose of 6000 mg/day), or a matching saline vehicle (placebo), given by continuous IV infusion for 3 consecutive days, in a blinded manner. Treatment will be initiated within 24 hours after ICH symptom onset. Subjects will undergo repeated clinical, imaging, and laboratory evaluations at regular intervals throughout their participation in the study, from the day of randomization until day 180. All adverse events will be assessed until day-7 or discharge (whichever is earlier), and serious adverse events until day-90. Mortality and continuing SAEs will be assessed until day 180. Functional status will be determined by mRS scores, in person at 30±7 and 90±7 days; the patients or their surrogates will be contacted by phone on days 60±7 and 180±7 to assess mRS.