Pilot Study of Epoetin Alfa for Patients Having Abdominal or Pelvic Surgery for Cancer
| Status: | Archived |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
Placebo-Controlled Pilot Study to Assess the Post-Operative Administration of Epoetin Alfa on Patients Undergoing Abdominal or Pelvic Surgery for Malignancy
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.
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 malignancy (esophagectomy, gastrectomy, partial hepatectomy, partial
pancreatectomy, or low anterior resection of rectum) and have a post-operative hemoglobin
greater than 8 g/dL and less than 11 g/dL on post-operative day #1. On post-operative day #1
patients enrolled in the study will be randomized to receive either 40,000 units of epoetin
alfa or placebo. On post-operative day #8, the patients will receive an additional dose of
epoetin alfa or placebo (depending on randomization assignment and Hgb level). Hemoglobin,
hematocrit, reticulocyte count, reticulocyte hemoglobin, and immature reticulocyte count
will be measured on days 1, 4, 8, and once between post-operative days 20 and 30.
Pre-operatively and between post-operative days 20 and 30 patients will complete a quality
of live assessment tool (FACT-An) to assess their fatigue related to anemia.
We found this trial at
1
site
University of Florida Gainesville UF has a long history of established programs in international education,...
Click here to add this to my saved trials
