Status:
TERMINATED
Treating Patients With Aneurysmal SubArachnoid Hemorrhage (SAH) With Epoetin Alfa
Lead Sponsor:
University of South Florida
Collaborating Sponsors:
Ortho Biotech, Inc.
Conditions:
Subarachnoid Hemorrhage
Eligibility:
All Genders
30-75 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00626574
Start Date
July 1 2007
End Date
February 1 2009
Last Update
July 31 2018
Active Locations (1)
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1
Tampa General Hospital
Tampa, Florida, United States, 33606