Intracerebral Hemorrhage Clinical Trial
Official title:
Study of Deferoxamine Mesylate in Intracerebral Hemorrhage
The investigators hypothesize that treatment with the iron chelator, Deferoxamine Mesylate,
improves the outcome of patients with brain hemorrhage.
The purpose of this study is to determine whether treatment with Deferoxamine Mesylate is of
sufficient promise to improve outcome before pursuing a larger clinical trial to examine its
effectiveness as a treatment for intracerebral hemorrhage.
This is a prospective, multi-center, double-blind, randomized, placebo-controlled, phase-II
clinical trial.
Subjects will be randomized to either deferoxamine mesylate (DFO) at 32 mg/kg/day (up to a
maximum daily dose of 6000 mg/day), or saline placebo, given by IV infusion for 3 consecutive
days.
Treatment will be initiated within 24 hours after ICH symptom onset. Randomization will
control baseline imbalances associated with baseline ICH score, ICH onset-to-treatment time
(OTT), ICH volume, baseline NIHSS score, and warfarin use.
All subjects will be followed for 6 months and will receive standard of care therapy while
participating in the study.
Throughout the study, we will continue to assess the safety of DFO. At the conclusion of the
study, the proportion of DFO-treated subjects with a good clinical outcome at 3 months
(defined as modified Rankin Scale (mRS) score of 0-2) will be compared to the placebo
proportion in a futility analysis to determine if it is futile to move DFO forward to Phase
III efficacy evaluation.
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