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

NCT00626574 | Terminated Phase 4 Results DMC

• 2 other identifiers: 105838cUSF 6176-P67638
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Keywords

Epoetin alfa; aneurysm; subarachnoid hemorrhage

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events After Administering Intravenous Doses of Procrit® Once Daily for Three Consecutive Days to Patients With Aneurysmal SAH Before and After Vascular Clipping

  Number of adverse events

  First 10 days following clipping and 6 week F/U

Secondary Outcomes (3)

• To Determine if Administration of Procrit® Prior to Aneurysm Clipping Reduces the Incidence of Vasospasm Following a SAH Event Treated by Vascular Clipping.

  first 10 days following clipping and 6 week f/u

• 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

  First 10 days following clipping and 6 week f/u

• 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.

  When all data is collected and analyzed

Study Arms (2)

A

ACTIVE COMPARATOR

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.

Drug: Epoetin alfa

B

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

Epoetin alfa 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.

Also known as: Procrit

A

Saline 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.

B

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead
• Ortho Biotech, Inc.: collaborator

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Aneurysm

Interventions

Epoetin Alfa; Sodium Chloride

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

In late October 2008, we received a letter from the sponsor requesting that we terminate any further work on this study.

Results Point of Contact

• Title: Enrico M Camporesi MD
• Organization: University of South Florida

ecampore@health.usf.edu

813-844-7170

Study Officials

• Enrico M Camporesi, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emeritus Professor, Dept of Surgery

Study Record Dates

• First Submitted: February 7, 2008
• First Posted: February 29, 2008
• Study Start: July 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: July 31, 2018
• Results First Posted: October 29, 2012

Record last verified: 2018-07

Locations

US (1)