Erythropoietin and Pediatric Cardiac Surgery (EPO)

This study has been terminated.
(Inadequate patient enrollment)
Sponsor:
Collaborators:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
Steven Zangwill, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00451698
First received: March 22, 2007
Last updated: July 25, 2013
Last verified: July 2013
Results First Received: March 21, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Condition: Congenital Heart Defect
Interventions: Drug: acyanotic erythropoietin
Drug: acyanotic placebo

  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
No text entered.

Reporting Groups
  Description
Acyanotic Placebo Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo
Acyanotic Study Drug Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug

Participant Flow:   Overall Study
    Acyanotic Placebo     Acyanotic Study Drug  
STARTED     3     6  
COMPLETED     3     6  
NOT COMPLETED     0     0  



  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
Acyanotic Placebo Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo
Acyanotic Study Drug Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
Total Total of all reporting groups

Baseline Measures
    Acyanotic Placebo     Acyanotic Study Drug     Total  
Number of Participants  
[units: participants]
  3     6     9  
Age  
[units: participants]
     
<=18 years     3     6     9  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  3.1  ± 1.2     12.9  ± 4.5     9.6  ± 6.1  
Gender  
[units: participants]
     
Female     0     0     0  
Male     3     6     9  
Region of Enrollment  
[units: participants]
     
United States     3     6     9  



  Outcome Measures
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1.  Primary:   Biochemical Markers of Heart Damage   [ Time Frame: 4 postoperative time points ]

2.  Secondary:   Length of Hospitalization   [ Time Frame: at hospital discharge ]

3.  Primary:   Biochemical Markers of Neuron Damage   [ Time Frame: 4 postoperative time points ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Primary:   Echocardiographic Assessment of Heart Function   [ Time Frame: 24 hours postop ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Inotropic Support   [ Time Frame: 24 and 48 hours post operative ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
Data for all recruited patients was included with available results. The number of participants fell far short of study goals and the study was terminated prematurely due to inadequate enrollment.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Steven Zangwill
Organization: Medical College of Wisconsin
phone: 414-266-2380
e-mail: szangwill@chw.org


Publications:

Responsible Party: Steven Zangwill, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00451698     History of Changes
Other Study ID Numbers: CHW 04/161
Study First Received: March 22, 2007
Results First Received: March 21, 2013
Last Updated: July 25, 2013
Health Authority: United States: Food and Drug Administration