Back to resultsRestrictive Versus Liberal Transfusion Protocol in Infants Undergoing Cardiac Surgery
Primary Purpose
Impaired Oxygen Delivery, Congenital Heart Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Red blood cell transfusion
Red blood cell transfusion
Sponsored by
About this trial
This is an interventional treatment trial for Impaired Oxygen Delivery focused on measuring Hemoglobin, Congenital heart disease, Cardiac surgery, Red blood cell transfusion, Number of red blood cell transfusions
Eligibility Criteria
Inclusion Criteria:
- children </= 6 months of age with congenital cardiac disease undergoing cardiac surgery with cardiopulmonary bypass.
Exclusion Criteria:
- presence of a known bleeding disorder or coagulopathy.
- age > 6 months,
- lack of informed consent.
Sites / Locations
- University of Rochester Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Restrictive transfusion strategy
Liberal RBC transfusion strategy
Arm Description
RBC will be transfused if the hemoglobin level falls below 7 for bi-ventricular repairs and under 9.0 for single ventricle palliations.
RBCs will be transfused for Hemoglobin under 9.5 for biventricular repairs and under 12 for single ventricle palliations.
Outcomes
Primary Outcome Measures
oxygen utilization derived from the arterio-venous oxygen difference.
Arterial and venous oxygen saturations will be measured every four hours x 48-72 hours and will be used to calculate arterio-venous oxygen content differences.
Secondary Outcome Measures
volume of RBC transfused
The total numbers of RBC transfusions given during the immediate post-op period (1st 7 days) will be compared between groups.
Full Information
NCT ID
NCT01484886
First Posted
November 12, 2011
Last Updated
September 4, 2014
Sponsor
University of Rochester
1. Study Identification
Unique Protocol Identification Number
NCT01484886
Brief Title
Restrictive Versus Liberal Transfusion Protocol in Infants Undergoing Cardiac Surgery
Official Title
Prospective Randomized Controlled Clinical Trial Comparing a Restrictive Versus Liberal Transfusion Strategy in Neonates and Infants Undergoing Surgery for Congenital Heart Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In neonates and infants </= 10 kg following cardiac surgery for congenital heart disease a more restrictive red blood cell (RBC) transfusion strategy will be as effective as, and possibly superior to, a liberal RBC strategy. Allowing lower hemoglobin concentration will not affect the cardiac or pulmonary status of the patient.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Oxygen Delivery, Congenital Heart Disease
Keywords
Hemoglobin, Congenital heart disease, Cardiac surgery, Red blood cell transfusion, Number of red blood cell transfusions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Restrictive transfusion strategy
Arm Type
Experimental
Arm Description
RBC will be transfused if the hemoglobin level falls below 7 for bi-ventricular repairs and under 9.0 for single ventricle palliations.
Arm Title
Liberal RBC transfusion strategy
Arm Type
Experimental
Arm Description
RBCs will be transfused for Hemoglobin under 9.5 for biventricular repairs and under 12 for single ventricle palliations.
Intervention Type
Other
Intervention Name(s)
Red blood cell transfusion
Intervention Description
10cc/kg weight RBC transfusion as needed according to hemoglobin level
Intervention Type
Other
Intervention Name(s)
Red blood cell transfusion
Intervention Description
10cc/kg body weight RBC will be transfused for hemoglobin under 9.5 for biventricular repairs and under 12 for single ventricle palliations.
Primary Outcome Measure Information:
Title
oxygen utilization derived from the arterio-venous oxygen difference.
Description
Arterial and venous oxygen saturations will be measured every four hours x 48-72 hours and will be used to calculate arterio-venous oxygen content differences.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
volume of RBC transfused
Description
The total numbers of RBC transfusions given during the immediate post-op period (1st 7 days) will be compared between groups.
Time Frame
7 days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
7 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children </= 6 months of age with congenital cardiac disease undergoing cardiac surgery with cardiopulmonary bypass.
Exclusion Criteria:
presence of a known bleeding disorder or coagulopathy.
age > 6 months,
lack of informed consent.
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
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Restrictive Versus Liberal Transfusion Protocol in Infants Undergoing Cardiac Surgery
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