Status:
COMPLETED
Pilot Study of Epoetin Alfa for Patients Having Abdominal or Pelvic Surgery for Cancer
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Ortho Biotech Clinical Affairs, L.L.C.
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This pilot study is looking at how well epoetin alfa, given in the immediate post-operative period, works in reducing anemia and the need for transfusions.
Detailed Description
This is a pilot, single center, prospective, double blinded, randomized study comparing epoetin alfa versus placebo. Eligible patients will just have undergone a major abdominal operation for malignan...
Eligibility Criteria
Inclusion
- Patients undergoing esophagectomy, gastrectomy, partial pancreatectomy, hepatic resection, or low anterior resection of rectum for malignancy
- Patients with hemoglobin greater than 8 and less than 11 g/dL on post-operative day #1.
Exclusion
- Patients receiving red blood cell transfusion within the first twelve hours post-operatively.
- Patients receiving epoetin-stimulating proteins within 30 days prior to the operation.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00294203
Start Date
February 1 2006
End Date
December 1 2008
Last Update
April 15 2014
Active Locations (2)
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1
Shands Hospital at the University of Florida
Gainesville, Florida, United States, 32610
2
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610