Futility Study of Deferoxamine Mesylate in Intracerebral Hemorrage (iDEF Trial)
ID Number 15-0510Principal Investigator(s)
Neha S Dangayach
Department(s) or Division(s)
There is an unmet need for safe and effective neuroprotective strategies to target the secondary effects of Intracerebral Hemorrage (ICH) in order to limit brain injury, facilitate neuronal repair, and improve functional outcome. The iron chelator, deferoxamine mesylate (DFO), is potentially promising as a candidate therapeutic intervention to improve the overall outcome of ICH patients.
This study is a prospective, multi-center, double-blind, randomized, placebo-controlled, phase-II clinical trial. Subjects will be randomized to either deferoxamine mesylate (DFO) at 32mg/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.
The number of people expected to take part in this research study at this site is 10, and the total number of people expected to take part in this research study is 294.
Recruiting Patients: Yes