Treating Patients With Aneurysmal SubArachnoid Hemorrhage (SAH) With Epoetin Alfa

This is a prospective, randomized, double-blinded, placebo controlled pilot safety study that
will enroll a total of twenty subjects. Subjects will be adults (30-75) who have sustained a
SAH secondary to cerebral aneurysm rupture and who present with minimal neurological
symptoms. All subjects will have a Hemoglobin less than or equal to 12 g/dL within 24 hours
prior to study entry and undergo operative aneurismal clipping. Subjects will be randomized
into two groups, ten subjects receiving the drug and ten subjects receiving the placebo. The
subjects will receive three intravenous injections of study drug or placebo, once before
undergoing operative aneurysmal clipping (study Day 1) and again for two additional days
(study Day 2 and study Day 3).

There are 3 phases to this trial:

Screening Phase - patients will present with Subarachnoid hemorrhage (SAH) and prepped for
surgery within 36 hours Treatment Phase - first pre-operative dose before surgery (Study Day
1), post-operative (Study Days 2 and 3) Follow-up Phase- Study Day 4 through discharge, 6-7
week follow-up Primary Objective: To determine the safety of administering intravenous doses
of Procrit® once daily for three consecutive days to patients with aneurysmal SAH before and
after vascular clipping by comparing the incidence of thrombotic events, hemoglobin and 6-7
week mortality between the Procrit® and placebo groups. Secondary Objectives: To determine if
administration of Procrit® prior to aneurysm clipping reduces the incidence of vasospasm
following a SAH event treated by vascular clipping. To determine if Procrit® administration
prior to aneurysm clipping in patients with Aneurysmal SAH will improve neurological
assessment scores in the post-SAH/post-clipping time period. To determine the feasibility of
organizing a larger, randomized study to explore the neuroprotective effect of Procrit® in
patients with Aneurysmal SubArachnoid Hemorrhage (SAH) when Procrit® is administered prior to
surgical clipping of the aneurysm.

It is hypothesized that Procrit will provide a significant level of neuroprotection in the
brain after an SAH event as a result of reduced cell death, as well as a reduced amount of
vasospasm activity and delayed cerebral ischemia which can occur as a result of SAH. These
factors may contribute to improved neurological functioning scores when compared to the
placebo treated patients.