Authors: Sharon D Yeatts Yuko Y Palesch Claudia S Moy Magdy Selim
Publish Date: 2013/08/13
Volume: 19, Issue: 2, Pages: 257-266
Abstract
Hemoglobin degradation products in particular iron have been implicated in secondary neuronal injury following intracerebral hemorrhage ICH The iron chelator Deferoxamine Mesylate DFO exerts diverse neuroprotective effects reduces perihematoma edema PHE and neuronal damage and improves functional recovery after experimental ICH We hypothesize that treatment with DFO could minimize neuronal injury and improve outcome in ICH patients As a prelude to test this hypothesis we conducted a Phase I openlabel study to determine the tolerability safety and maximum tolerated dose MTD of DFO in patients with ICH Intravenous infusions of DFO in doses up to 62 mg/kg/day up to a maximum of 6000 mg/day were welltolerated and did not seem to increase serious adverse events SAEs or mortality We have initiated a multicenter doubleblind randomized placebocontrolled Phase II clinical trial High Dose Deferoxamine HIDEF in Intracerebral Hemorrhage to determine if it is futile to move DFO forward to Phase III efficacy evaluationWe will randomize 324 subjects with spontaneous ICH to either DFO at 62 mg/kg/day up to a maximum daily dose of 6000 mg/day or saline placebo given by intravenous infusion for 5 consecutive days Treatment will be initiated within 24 hours after ICH symptom onset All subjects will be followed for 3 months and will receive standard of care therapy while participating in the study At 3 months the proportion of DFOtreated subjects with a good clinical outcome assessed by modified Rankin Scale will be compared to the placebo proportion in a futility analysis
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