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

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: August 28, 2012

Last verified: August 2012

History of Changes

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
Intervention:	Drug: Epoetin alfa

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
PROCRIT	PROCRIT (epoetin alfa) 300 IU/kg/day
STANDARD THERAPY	Standard of Care

Participant Flow: Overall Study

	PROCRIT	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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Reporting Groups

	Description
PROCRIT	PROCRIT (epoetin alfa) 300 IU/kg/day
STANDARD THERAPY	Standard of Care
Total	Total of all reporting groups

Baseline Measures

	PROCRIT	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 Patients Receiving pRBC (Packed Red Blood Cell) Transfusions. [ Time Frame: Day of surgery until hospital discharge ]

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: All information which is supplied by COBS to the investigator & not previously published & any data generated as a result of the study are confidential & remain the sole property of COBS. Investigator will not use the information for other purposes without COBS prior written consent.

Limitations and Caveats

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.

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
Study First Received:	July 7, 2006
Results First Received:	February 20, 2009
Last Updated:	August 28, 2012
Health Authority:	United States: Food and Drug Administration

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