Treating Patients With Aneurysmal SubArachnoid Hemorrhage (SAH) With Epoetin Alfa (EPO)
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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 |
- 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
- 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 |
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| United States, Florida | |
| Tampa General Hospital | |
| Tampa, Florida, United States, 33606 | |
| 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 Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Epoetin Alfa Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013