Treating Patients With Aneurysmal SubArachnoid Hemorrhage (SAH) With Epoetin Alfa
Condition: Subarachnoid Hemorrhage
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage
Intervention: Epoetin alfa; Saline
Intervention description: Intravenous administration of epoetin alfa (40,000 IU) immediately before clipping surgery. Successive doses will be given 24 and 48 hours after the first dose.; 3ml of saline will be administered via an IV push immediately before clipping surgery. Successive doses will be given 24 and 48 hours after the first dose.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Epoetin alfa; aneurysm; subarachnoid hemorrhage

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients age 30-75

          -  Patients undergoing vascular clipping post SAH

          -  Aneurysmal SAH as determined by history or clinical evaluation

          -  WFNS Score I and II

          -  Hb ≤ 12 g/dL within 36 hours prior to first dose of study drug

          -  Patients who receive Study drug and undergo surgical clipping of the aneurysm within
             36 hours of the SAH event

        Exclusion Criteria:

          -  Non-aneurysmal SAH

          -  WFNS Score III and higher

          -  Patients presenting with previous history of SAH

          -  Terminal, brain-dead, comfort care patients

          -  Patients not undergoing vascular clipping

          -  Hb > 12 g/dL

          -  Patients receiving blood transfusion prior to surgery

          -  Patients who currently receive Procrit or an EPO product

          -  Patients undergoing surgical clipping of the aneurysm greater than 36 hours after the
             SAH event

          -  Pregnancy or lactating

          -  Renal insufficiency (must present and maintain normal creatinine levels)

          -  Uncontrolled hypertension (systolic > 150 mmHg)

          -  Active or known seizure history within one year of SAH event

          -  Known history of thrombotic vascular events (PE, DVT, AMI, stroke)

          -  Allergy or sensitivity to mammalian derived products