Transfusion Strategies in Pediatric Cardiothoracic Surgery

This study has been completed.
Sponsor:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00350220
First received: July 5, 2006
Last updated: February 11, 2010
Last verified: January 2010
Results First Received: January 19, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Congenital Heart Disease
Interventions: Other: transfusion strategy
Other: Low Hb transfusion group

  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
High Hemoglobin (Liberal) Group High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.
Low Hb (Restrictive) Group Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.

Participant Flow:   Overall Study
    High Hemoglobin (Liberal) Group     Low Hb (Restrictive) Group  
STARTED     30     30  
COMPLETED     30     30  
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
High Hemoglobin (Liberal) Group High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.
Low Hb (Restrictive) Group Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
Total Total of all reporting groups

Baseline Measures
    High Hemoglobin (Liberal) Group     Low Hb (Restrictive) Group     Total  
Number of Participants  
[units: participants]
  30     30     60  
Age [1]
[units: participants]
     
<=18 years     30     30     60  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  2.75  ± 1.9     2.25  ± 1.8     2.5  ± 1.8  
Gender  
[units: participants]
     
Female     13     13     26  
Male     17     17     34  
Region of Enrollment  
[units: participants]
     
United States     30     30     60  
[1] subjects under 8 years of age included



  Outcome Measures
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1.  Primary:   Mean Arterial Lactate Level   [ Time Frame: 48 hours ]

2.  Primary:   Peak Arterial Lactate Level   [ Time Frame: 48 hours ]

3.  Secondary:   Oxygen Utilization During the 8 Hour to 72 Hours Post-operative Period.   [ Time Frame: 3 days ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Length of Mechanical Ventilation   [ Time Frame: 3 days ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Length of Oxygen Use   [ Time Frame: 3 days ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Length of Vasoactive Agent Administration   [ Time Frame: 3 days ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Volume of Blood Transfused   [ Time Frame: 3 days ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Mortality Before Hospital Discharge   [ Time Frame: 30 days ]
Results not yet posted.   Anticipated Posting 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
There were no limitations to this study. There was 100% compliance with study procedures. There were no adverse events.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Jill M. Cholette MD
Organization: University of Rochester Medical Center
phone: 585-275-0189
e-mail: Jill_Cholette@urmc.rochester.edu


No publications provided


Responsible Party: Jill M. Cholette MD, URMC
ClinicalTrials.gov Identifier: NCT00350220     History of Changes
Other Study ID Numbers: 12408
Study First Received: July 5, 2006
Results First Received: January 19, 2010
Last Updated: February 11, 2010
Health Authority: United States: Food and Drug Administration