Overview

The Safety and Effectiveness of PROCRIT (Epoetin Alfa) in Patients Undergoing Elective Major Abdominal and/or Pelvic Surgery

Status:
Terminated

Trial end date:
2008-02-01

Target enrollment:
0

Participant gender:
All

Summary

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).

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Collaborator:

Ortho Biotech Clinical Affairs, L.L.C.

Treatments:

Epoetin Alfa

Criteria

Inclusion Criteria: - Scheduled to undergo elective major abdominal and/or pelvic surgery
with anticipated significant perioperative ((the time period describing the duration of a
participants surgical procedure) blood loss (eg, greater than 500 cc and at increased risk
for blood transfusion) - Hemoglobin greater than 10 g/dL and less than or equal to 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 (eg, 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 - 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 greater than 6
transfusions perioperatively - No prior treatment with PROCRIT or any
erythropoiesis-stimulating agents (ESAs) within the previous month