The Safety and Effectiveness of PROCRIT (Epoetin Alfa) in Patients Undergoing Elective Major Abdominal and/or Pelvic Surgery
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|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|
|Actual Primary Completion Date :||February 2008|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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.|