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

NCT00350519 | Terminated Phase 4 Results

• 2 other identifiers: CR012460EPOSUR4005
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Hemostasis, Surgical

Keywords

Hemostasis, Surgical; Epoetin alfa; Surgery; Abdomen; Pelvis; PROCRIT; pRBC; Blood transfusion; Packed red blood cell transfusion

Outcome Measures

Primary Outcomes (1)

• Number of Participants Receiving pRBC (Packed Red Blood Cell) Transfusions

  Day of surgery until hospital discharge

Secondary Outcomes (3)

• 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

Study Arms (2)

PROCRIT (epoetin alfa)

EXPERIMENTAL

Participants will receive PROCRIT (epoetin alfa).

Drug: Epoetin alfa

STANDARD THERAPY

EXPERIMENTAL

Participants will receive standard of care.

Drug: Standard of Care

Interventions

Epoetin alfa DRUG

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.

Also known as: PROCRIT

PROCRIT (epoetin alfa)

Standard of Care DRUG

Participants will receive standard of care based on the Institution's treatment policy.

STANDARD THERAPY

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Ortho Biotech Clinical Affairs, L.L.C.: collaborator

MeSH Terms

Interventions

Epoetin Alfa; Standard of Care

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

No formal analysis was conducted due to early termination.

Results Point of Contact

• Title: Vice President Medical Affairs COBS
• Organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

215-325-4464

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2006
• First Posted: July 10, 2006
• Study Start: August 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: July 22, 2013
• Results First Posted: May 6, 2009

Record last verified: 2013-07