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

This study has been terminated.
(This study is terminated as a result of data from a study that showed increased mortality in stroke patients.)
Sponsor:
Collaborator:
Ortho Biotech, Inc.
Information provided by (Responsible Party):
Enrico Camporesi, University of South Florida
ClinicalTrials.gov Identifier:
NCT00626574
First received: February 7, 2008
Last updated: September 25, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Subarachnoid Hemorrhage
Drug: Epoetin alfa
Drug: Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blinded, Placebo Controlled, Pilot Study to Evaluate the Safety of Treating Patients With Aneurysmal SubArachnoid Hemorrhage (SAH) With Epoetin Alfa

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • 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 [ Time Frame: First 10 days following clipping and 6 week F/U ] [ Designated as safety issue: Yes ]
    Number of adverse events


Secondary Outcome Measures:
  • To Determine if Administration of Procrit® Prior to Aneurysm Clipping Reduces the Incidence of Vasospasm Following a SAH Event Treated by Vascular Clipping. [ Time Frame: first 10 days following clipping and 6 week f/u ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: First 10 days following clipping and 6 week f/u ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: When all data is collected and analyzed ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: July 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: 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.
Other Name: Procrit
Placebo Comparator: B
Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626574

Locations
United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
Sponsors and Collaborators
University of South Florida
Ortho Biotech, Inc.
Investigators
Principal Investigator: Enrico M Camporesi, MD University of South Florida
  More Information

No publications provided

Responsible Party: Enrico Camporesi, Emeritus Professor, Dept of Surgery, University of South Florida
ClinicalTrials.gov Identifier: NCT00626574     History of Changes
Other Study ID Numbers: 105838c, USF 6176-P67638
Study First Received: February 7, 2008
Results First Received: September 8, 2011
Last Updated: September 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of South Florida:
Epoetin alfa
aneurysm
subarachnoid hemorrhage

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Vascular Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014