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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
Sponsor:
Information provided by (Responsible Party):
jill cholette, University of Rochester

Study Description
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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.

Condition or disease Intervention/treatment Phase
Impaired Oxygen Delivery Congenital Heart Disease Other: Red blood cell transfusion Not Applicable

Study Design
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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

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Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.
 Other: Red blood cell transfusion
10cc/kg weight RBC transfusion as needed according to hemoglobin level
Experimental: Liberal RBC transfusion strategy
RBCs will be transfused for Hemoglobin under 9.5 for biventricular repairs and under 12 for single ventricle palliations.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   up to 7 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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


Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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