Resident Physician University of Michigan Ann Arbor, Michigan, United States
Introduction: Subarachnoid hemorrhage (SAH) is one of the most devastating forms of stroke, with the highest immediate mortality of all strokes and leading to severe disability. During SAH, the brain is exposed to iron, which increases the incidence of cerebral edema, ischemia, and hydrocephalus. Deferoxamine mesylate (DFO), a hydrophilic chelator, creates a stable complex with free iron, preventing the formation of iron related free radicals. Given the data involving DFO use in SAH animal models and recent human data with DFO use in intracranial hemorrhage, a clinical trial to determine the safety and efficacy of deferoxamine treatment in the human SAH population can provide data to change the current treatment paradigm.
Methods: This is a multi-center, prospective, randomized, double-blinded clinical trial. A total of 120 patients presenting with aneurysmal SAH are being randomized to a treatment group (DFO 32 mg/kg or 48 mg/kg) or a placebo (normal saline) group. Subjects receive three doses of the randomly assigned study drug or placebo. The first 50 patients are randomized into each group and then an interim analysis will be completed to implement a dose response adaptive randomization for the remainder of the trial. The primary objective of this trial is to determine if the administration of DFO in aSAH patients will identify a dose that has a 50% or greater chance of being at least 0.1 points greater on the 6-month utility weighted modified Rankin Scale. Secondary outcomes include incidence of delayed cerebral ischemia, need for chronic CSF diversion and cognitive outcomes.
Results: At this time, the trial is ongoing and blinding continues to remain in place. There are 9 patients enrolled with zero serious adverse events.
Conclusion : We aim to present the safety and feasibility data of this trial with neurological outcomes pending unblinding once patient accrual has reached the predetermined threshold.
