Restrictive Versus Liberal Transfusion Protocol in Infants Undergoing Cardiac Surgery
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ClinicalTrials.gov Identifier: NCT01484886 |
Recruitment Status
:
Completed
First Posted
: December 2, 2011
Last Update Posted
: September 5, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Impaired Oxygen Delivery Congenital Heart Disease | Other: Red blood cell transfusion | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 162 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | January 2012 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | September 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: Restrictive transfusion strategy
RBC will be transfused if the hemoglobin level falls below 7 for bi-ventricular repairs and under 9.0 for single ventricle palliations.
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Other: Red blood cell transfusion
10cc/kg weight RBC transfusion as needed according to hemoglobin level
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Experimental: Liberal RBC transfusion strategy
RBCs will be transfused for Hemoglobin under 9.5 for biventricular repairs and under 12 for single ventricle palliations.
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Other: Red blood cell transfusion
10cc/kg weight RBC transfusion as needed according to hemoglobin level
Other: Red blood cell transfusion
10cc/kg body weight RBC will be transfused for hemoglobin under 9.5 for biventricular repairs and under 12 for single ventricle palliations.
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- oxygen utilization derived from the arterio-venous oxygen difference. [ Time Frame: 3 days ]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.
- volume of RBC transfused [ Time Frame: 7 days ]The total numbers of RBC transfusions given during the immediate post-op period (1st 7 days) will be compared between groups.

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Ages Eligible for Study: | up to 7 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01484886
United States, New York | |
University of Rochester Medical Center | |
Rochester, New York, United States, 14642 |
Responsible Party: | jill cholette, Assistant Professor of Pediatrics, University of Rochester |
ClinicalTrials.gov Identifier: | NCT01484886 History of Changes |
Other Study ID Numbers: |
38569 |
First Posted: | December 2, 2011 Key Record Dates |
Last Update Posted: | September 5, 2014 |
Last Verified: | September 2014 |
Keywords provided by jill cholette, University of Rochester:
Hemoglobin Congenital heart disease Cardiac surgery Red blood cell transfusion Number of red blood cell transfusions |
Additional relevant MeSH terms:
Heart Diseases Heart Defects, Congenital Cardiovascular Diseases Cardiovascular Abnormalities Congenital Abnormalities |