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:
University of South Florida
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
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Results First Received: September 8, 2011
| 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 |
| Condition: |
Subarachnoid Hemorrhage |
| Interventions: |
Drug: Epoetin alfa Drug: Saline |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Procrit | 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. |
| Saline | Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3). |
Participant Flow: Overall Study
| Procrit | Saline | |
|---|---|---|
| STARTED | 2 | 1 |
| COMPLETED | 2 | 1 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Procrit | 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. |
| Saline | Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3). |
| Total | Total of all reporting groups |
Baseline Measures
| Procrit | Saline | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
2 | 1 | 3 |
|
Age
[units: participants] |
|||
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 1 | 3 |
| >=65 years | 0 | 0 | 0 |
|
Gender
[units: participants] |
|||
| Female | 2 | 1 | 3 |
| Male | 0 | 0 | 0 |
|
Region of Enrollment
[units: participants] |
|||
| United States | 2 | 1 | 3 |
Outcome Measures
| 1. Primary: | 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 ] |
| 2. Secondary: | 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 ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
No
| 3. Secondary: | 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 ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
No
| 4. Secondary: | 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 ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
No
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| 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:
Name/Title: Enrico M Camporesi MD
Organization: University of South Florida
phone: 813-844-7170
e-mail: ecampore@health.usf.edu
Organization: University of South Florida
phone: 813-844-7170
e-mail: ecampore@health.usf.edu
No publications provided
| Responsible Party: | Enrico Camporesi, 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 |