The Safety and Effectiveness of PROCRIT (Epoetin Alfa) in Patients Undergoing Elective Major Abdominal and/or Pelvic Surgery
|ClinicalTrials.gov Identifier: NCT00350519|
Recruitment Status : Terminated (The study was stopped due to slow enrollment)
First Posted : July 10, 2006
Results First Posted : May 6, 2009
Last Update Posted : July 22, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hemostasis, Surgical||Drug: Epoetin alfa Drug: Standard of Care||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Multicenter, Randomized, Controlled Study to Evaluate Efficacy and Safety of PROCRIT in Subjects Undergoing Elective Major Abdominal and/or Pelvic Surgery|
|Study Start Date :||August 2006|
|Primary Completion Date :||February 2008|
|Study Completion Date :||February 2008|
Experimental: PROCRIT (epoetin alfa)
Participants will receive PROCRIT (epoetin alfa).
Drug: Epoetin alfa
Participants will receive epoetin alfa 300 IU/kg once daily subcutaneously for 10 days prior to surgery, on the day of surgery, and for four days after surgery.
Other Name: PROCRIT
Experimental: STANDARD THERAPY
Participants will receive standard of care.
Drug: Standard of Care
Participants will receive standard of care based on the Institution's treatment policy.
- Number of Participants Receiving pRBC (Packed Red Blood Cell) Transfusions [ Time Frame: Day of surgery until hospital discharge ]
- Hemoglobin Change From Baseline to End of Study [ Time Frame: Baseline (Day-10) to end of study (Day 32) ]End of Study Hemoglobin minus baseline Hemoglobin
- Number of pRBC Units Transfused During Study [ Time Frame: Baseline (Day -10) to end of study (Day 32) ]
- Hospital Length of Stay [ Time Frame: Surgery to hospital discharge ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00350519
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|