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

This study has been terminated.
(The study was stopped due to slow enrollment)
Sponsor:
Collaborator:
Ortho Biotech Clinical Affairs, L.L.C.
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00350519
First received: July 7, 2006
Last updated: July 2, 2013
Last verified: July 2013
Results First Received: February 20, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hemostasis, Surgical
Interventions: Drug: Epoetin alfa
Drug: Standard of Care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
37 participants were enrolled in the study. 18 participants were randomly assigned to the epoetin alfa group and 19 were randomly assigned to the Standard therapy group.

Reporting Groups
  Description
PROCRIT (Epoetin Alfa) Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
STANDARD THERAPY Participants received standard of care based on the Institution’s treatment policy

Participant Flow:   Overall Study
    PROCRIT (Epoetin Alfa)     STANDARD THERAPY  
STARTED     18     19  
COMPLETED     14     13  
NOT COMPLETED     4     6  
Death                 0                 1  
Physician Decision                 0                 1  
Protocol Violation                 1                 2  
Withdrawal by Subject                 3                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
PROCRIT (Epoetin Alfa) Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
STANDARD THERAPY Participants received standard of care based on the Institution’s treatment policy
Total Total of all reporting groups

Baseline Measures
    PROCRIT (Epoetin Alfa)     STANDARD THERAPY     Total  
Number of Participants  
[units: participants]
  18     19     37  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     11     12     23  
>=65 years     7     7     14  
Age  
[units: years]
Mean ± Standard Deviation
  63.06  ± 16.17     61.42  ± 18.32     62.22  ± 17.08  
Gender  
[units: participants]
     
Female     13     10     23  
Male     5     9     14  
Race/Ethnicity, Customized  
[units: participants]
     
Black or Aftrican American     0     5     5  
Other     1     2     3  
White     17     12     29  



  Outcome Measures
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1.  Primary:   Number of Participants Receiving pRBC (Packed Red Blood Cell) Transfusions   [ Time Frame: Day of surgery until hospital discharge ]

2.  Secondary:   Hemoglobin Change From Baseline to End of Study   [ Time Frame: Baseline (Day-10) to end of study (Day 32) ]

3.  Secondary:   Number of pRBC Units Transfused During Study   [ Time Frame: Baseline (Day -10) to end of study (Day 32) ]

4.  Secondary:   Hospital Length of Stay   [ Time Frame: Surgery to hospital discharge ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No formal analysis was conducted due to early termination.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Vice President Medical Affairs COBS
Organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
phone: 215-325-4464


No publications provided


Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00350519     History of Changes
Other Study ID Numbers: CR012460, EPOSUR4005
Study First Received: July 7, 2006
Results First Received: February 20, 2009
Last Updated: July 2, 2013
Health Authority: United States: Food and Drug Administration