NCT00350519|TerminatedPhase 4Results
Study Stopped
The study was stopped due to slow enrollment
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The study was stopped due to slow enrollment
An Open Label, Multicenter, Randomized, Controlled Study to Evaluate Efficacy and Safety of PROCRIT in Subjects Undergoing Elective Major Abdominal and/or Pelvic Surgery
Sponsor study identifier
Secondary identifiers
OTHER · Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
interventional
37
0 countries
N/A
Study Start
August 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2008
Actual (reported)Study Completion
February 2008
Actual (reported)The primary purpose of the study is to compare the effect of perioperative (the time period describing the duration of a participants surgical procedure) administration of PROCRIT to that of Standard of Care (SOC) on the proportion of participants receiving pRBC (packed red blood cells) transfusions (from the day of surgery to the day of hospital discharge) in participants undergoing elective major abdominal and/or pelvic surgery. Standard of Care is defined as the treatment of participants according to the hospital or institution's policy, but where participants will not receive PROCRIT (Epoetin alfa) or any other erythropoiesis-stimulating agents (ESAs) (agents that stimulate the production of red blood cells in the bone marrow).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 7, 2006
Actual (reported)July 10, 2006
Actual (reported)August 2006
Date type not reportedThis date has not been verified as actual or estimated.
February 2008
Actual (reported)February 2008
Actual (reported)May 6, 2009
Actual (reported)Number of Participants Receiving pRBC (Packed Red Blood Cell) Transfusions
Day of surgery until hospital discharge
Hemoglobin Change From Baseline to End of Study
Baseline (Day-10) to end of study (Day 32)
Number of pRBC Units Transfused During Study
Baseline (Day -10) to end of study (Day 32)
Hospital Length of Stay
Surgery to hospital discharge
Participants will receive PROCRIT (epoetin alfa).
Participants will receive standard of care.
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.
Participants will receive standard of care based on the Institution's treatment policy.
Contact the study team to confirm eligibility.
No formal analysis was conducted due to early termination.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
37 participants (actual enrollment reported by the registry).
First Submitted
July 7, 2006
First Posted
July 10, 2006
Study Start
August 2006
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Primary Completion
February 2008
Actual (reported)Study Completion
February 2008
Actual (reported)Last Updated
July 22, 2013
Results First Posted
May 6, 2009
Record last verified: 2013-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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