The Safety and Effectiveness of PROCRIT (Epoetin Alfa) in Reducing the Number of Blood Transfusions Required by Patients Undergoing Elective Major Abdominal and/or Pelvic Surgery
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hemostasis, Surgical
Intervention: Epoetin alfa (Drug)
Phase: Phase 4
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
The primary objective of this study is to compare the effect of giving PROCRIT (Epoetin alfa)
to patients before, during and after elective major abdominal surgery (perioperatively) to
that of patients receiving Standard of Care (SOC) on the proportion of patients receiving
pRBC (packed red blood cell) transfusions from day of surgery to the day of hospital
discharge. Standard of Care is defined as the treatment of patients according to the
hospital or institution's policy, but where patients 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).
Official title: An Open-Label, Multicenter, Randomized, Controlled Study to Evaluate Efficacy and Safety of PROCRIT® in Subjects Undergoing Elective Major Abdominal or Pelvic Surgery
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary endpoint is the proportion of patients receiving pRBC (packed red blood cell) transfusions from the day of surgery until hospital discharge in the PROCRIT (Epoetin alfa) group vs. Standard of Care (SOC).
Secondary outcome: The effect of PROCRIT (Epoetin alfa) vs. SOC on hemoglobin, reticulocytes, total number of pRBC transfusions, and length of hospital stay.
This is a randomized, parallel-arm, open-label, multicenter study of up to 64 days duration
(Screening Phase of 21 days, Treatment Phase of 15 days, Follow-up Phase of 28 days).
Approximately 110 patients undergoing elective major abdominal and/or pelvic surgery with
anticipated significant perioperative blood loss (e. g. > 500 mL) and a hemoglobin (Hg) >10 to
<=13 g/dL at the baseline will be enrolled. During the Treatment Phase, eligible patients
will be randomly assigned (patients are assigned to a treatment group based on chance) in a
1: 1 ratio to either PROCRIT (Epoetin alfa) or the Standard of Care (SOC) group that will not
receive any erythropoiesis-stimulating agents (ESAs). Patients in the PROCRIT (Epoetin alfa)
group will receive a daily dose of PROCRIT (Epoetin alfa) 300 IU/kg daily for a maximum of
15 doses administered subcutaneously (under the skin). Patients in the SOC group will be
treated per the hospital/institution's policy but will not receive PROCRIT (Epoetin alfa) or
any other erythropoiesis-stimulating agents (ESAs). Patients will undergo surgery during the
Treatment Phase. After surgery, all patients will stay in the study for 4 days (or until
hospital discharge) and followed for an additional 28 days (Follow-up Phase). Safety and
efficacy evaluations will be performed at specified intervals throughout the study and will
consist of assessment of laboratory tests (Complete Blood Count [CBC] [including hemoglobin
level], Serum Chemistry), vital signs (such as blood pressure), physical examinations and the
occurrence and severity of adverse events. All patients enrolled in this study (regardless
of treatment group) will receive pharmacologic (i. e. anticoagulant) and/or non-pharmacologic
prophylaxis (prevention) for deep vein thrombosis (DVT) according to each site's Standard of
Care. Patients in the PROCRIT (Epoetin alfa) group will receive iron supplementation while
the SOC group will received iron based on the hospital/institution's iron treatment policy.
Patients in the PROCRIT (Epoetin alfa) group will receive 300 IU/kg daily administered under
the skin (SC) for a maximum of 15 doses. PROCRIT (Epoetin alfa) will be administered daily
for 10 days prior to surgery, on the day of surgery and daily for four days after surgery.
Minimum age: 18 Years.
Maximum age: N/A.
- Scheduled to undergo elective major abdominal and/or pelvic surgery with anticipated
significant perioperative blood loss (e. g. >500 cc and at increased risk for blood
- Hemoglobin > 10 g/dL and <= 13 g/dL at screening (Day -13 (13 days prior to surgery)
to Day - 11) and baseline (Day -10)
- Patients with reproductive potential and their partners must practice an effective
method of birth control (e. g., prescription oral contraceptives, contraceptive
injections, intrauterine device, double-barrier method, contraceptive patch, partner
sterilization) before entry and throughout the study
- Female patients with reproductive potential must have a negative urine pregnancy test
within 7 days of the first dose of PROCRIT (Epoetin alfa)
- Adequate renal (kidney) and adequate hepatic (liver) function assessed within the
21-day screening period
- No severe Congestive Heart Failure (New York Heart Association Class IV)
- No known severe stable or unstable coronary artery disease, or unstable angina
- No history of deep venous thrombosis (DVT) or pulmonary embolus (PE) within 12 months
before study entry (Prior superficial thrombophlebitis is not an exclusion criterion)
- No history of cerebrovascular accident (CVA), transient ischemic attack (TIA), Acute
Coronary Syndrome (Unstable Angina, Myocardial Infarction), or other arterial
thrombosis within 6 months before study entry
- Not anticipated to donate perioperative autologous blood or receive transfusions
within 21 days prior to baseline or to have > 6 transfusions perioperatively
- No prior treatment with PROCRIT or any erythropoiesis-stimulating agents(ESAs) within
the previous month
Locations and Contacts
For FDA Approved Product labeling, refer to the following link:http://www.accessdata.fda.gov/scripts/cder/drugsatfda/
Additional information is provided at the following link;http://dailymed.nlm.nih.gov/dailymed/about.cfm
For FDA Safety Alerts and Recalls refer to the following link:www.fda.gov/MEDWATCH/safety.htm
Starting date: July 2006
Ending date: February 2008
Last updated: April 14, 2008