Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00294203
Status:
COMPLETED
Last Update Posted:
2014-04-15
First Post:
2006-02-17
Brief Title:
Pilot Study of Epoetin Alfa for Patients Having Abdominal or Pelvic Surgery for Cancer
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Placebo-Controlled Pilot Study to Assess the Post-Operative Administration of Epoetin Alfa on Patients Undergoing Abdominal or Pelvic Surgery for Malignancy
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 malignancy esophagectomy gastrectomy partial hepatectomy partial pancreatectomy or low anterior resection of rectum and have a post-operative hemoglobin greater than 8 gdL and less than 11 gdL on post-operative day 1 On post-operative day 1 patients enrolled in the study will be randomized to receive either 40000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20052318 | None | None | None |