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

NCT ID: NCT00626574

Last Updated: 2018-07-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2009-02-28

Brief 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.

Conditions

Subarachnoid Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

A

Group A will receive Procrit® intravenous injections (40,000U) once daily for 3 days (Study Days 1, 2, and 3). The first dose of Procrit® will be given within 36 hours of the initial SAH event / symptoms and immediately before the vascular clipping procedure.

Group Type: ACTIVE_COMPARATOR

Epoetin alfa

Intervention Type: DRUG

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.

B

Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

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.

Interventions

Epoetin alfa

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.

Intervention Type: DRUG

Saline

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 Type: DRUG

Other Intervention Names

Procrit

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ortho Biotech, Inc.

INDUSTRY

Sponsor Role: collaborator

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Enrico Camporesi

Emeritus Professor, Dept of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enrico M Camporesi, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

Tampa General Hospital

Tampa, Florida, United States

Countries

United States

Other Identifiers

USF 6176-P67638

Identifier Type: -

Identifier Source: secondary_id

105838c

Identifier Type: -

Identifier Source: org_study_id