Intracerebral Hemorrhage Clinical Trial
Official title:
Safety and Tolerability of Deferoxamine in Acute Cerebral Hemorrhage
Animal studies show that the breakdown of blood results in iron accumulation in the brain
after brain hemorrhage (ICH); and that iron plays a role in brain injury in ICH patients.
Deferoxamine (DFO) has been extensively used in clinical practice for more than 30 years to
remove excessive iron from the body, and has been shown to provide some benefit in animal
studies of ICH. Therefore, we plan to undertake this study to evaluate the safety and
tolerability of treatment with DFO in patients with ICH, and to determine the maximal
tolerated dose to be used in future studies to determine if treatment with DFO can improve
the outcome of patients with ICH.
Our main objectives are: 1) to evaluate the safety and tolerability of varying doses of DFO,
by determining the treatment related adverse events, in patients with ICH; and 2) to
determine the maximal tolerated dose to be adopted in subsequent studies to test the efficacy
of DFO in improving outcome after ICH.
We hypothesize that DFO is well-tolerated and has minimal serious adverse effects in patients
with ICH; and that treatment with DFO will improve patients' outcome. The results can
potentially bring into account new means to improve the outcome of patients with ICH. ICH is
a frequent cause of disability and death. A successful study demonstrating the efficacy of
iron-modifying therapy would be of considerable public health significance.
An open-label, safety, tolerability, and dose-finding study using the continuous reassessment method. ;
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