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

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ClinicalTrials.gov Identifier: NCT00626574
Recruitment Status : Terminated (This study is terminated as a result of data from a study that showed increased mortality in stroke patients.)
First Posted : February 29, 2008
Results First Posted : October 29, 2012
Last Update Posted : July 31, 2018
Sponsor:
Collaborator:
Ortho Biotech, Inc.
Information provided by (Responsible Party):
Enrico Camporesi, University of South Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Subarachnoid Hemorrhage
Interventions Drug: Epoetin alfa
Drug: Saline
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Procrit Saline
Hide Arm/Group Description 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 B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
Period Title: Overall Study
Started 2 1
Completed 2 1
Not Completed 0 0
Arm/Group Title Procrit Saline Total
Hide Arm/Group Description 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 B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3). Total of all reporting groups
Overall Number of Baseline Participants 2 1 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
1
 100.0%
3
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
Female
2
 100.0%
1
 100.0%
3
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 1 participants 3 participants
2 1 3
1.Primary Outcome
Title 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
Hide Description Number of adverse events
Time Frame First 10 days following clipping and 6 week F/U
Hide Outcome Measure Data
Hide Analysis Population Description
Pilot Study- per protocol
Arm/Group Title Procrit Saline
Hide Arm/Group Description:
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 B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
Overall Number of Participants Analyzed 2 1
Measure Type: Number
Unit of Measure: adverse events
1 2
2.Secondary Outcome
Title To Determine if Administration of Procrit® Prior to Aneurysm Clipping Reduces the Incidence of Vasospasm Following a SAH Event Treated by Vascular Clipping.
Hide Description [Not Specified]
Time Frame first 10 days following clipping and 6 week f/u
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated prematurely. Outcome measures were not analyzed.
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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.

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.

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

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame First 10 days following clipping and 6 week f/u
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated prematurely and outcome measures were not analyzed.
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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.

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.

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

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame When all data is collected and analyzed
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated prematurely and outcome measures were not analyzed.
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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.

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.

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

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Procrit Saline
Hide Arm/Group Description 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 B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
All-Cause Mortality
Procrit Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Procrit Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      1/1 (100.00%)    
Nervous system disorders     
Severe Headache   0/2 (0.00%)  0 1/1 (100.00%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Procrit Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/2 (50.00%)      1/1 (100.00%)    
Renal and urinary disorders     
Urinary Tract Infection *  0/2 (0.00%)  0 1/1 (100.00%)  1
Vascular disorders     
Pseudo aneurysm left groin  1/2 (50.00%)  1 0/1 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
In late October 2008, we received a letter from the sponsor requesting that we terminate any further work on this study.
Certain Agreements
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.
Results Point of Contact
Name/Title: Enrico M Camporesi MD
Organization: University of South Florida
Phone: 813-844-7170
Responsible Party: Enrico Camporesi, University of South Florida
ClinicalTrials.gov Identifier: NCT00626574     History of Changes
Other Study ID Numbers: 105838c
USF 6176-P67638
First Submitted: February 7, 2008
First Posted: February 29, 2008
Results First Submitted: September 8, 2011
Results First Posted: October 29, 2012
Last Update Posted: July 31, 2018