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

Condition(s) targeted: Hemostasis, Surgical

Intervention: Epoetin alfa (Drug)

Phase: Phase 4

Status: Terminated

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.

Detailed description: 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. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 transfusion)

- 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

Exclusion Criteria:

- 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

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