Restrictive Versus Liberal Transfusion Protocol in Infants Undergoing Cardiac Surgery

This study is currently recruiting participants.

Verified February 2013 by University of Rochester

Sponsor:

Information provided by (Responsible Party):

jill cholette, University of Rochester

ClinicalTrials.gov Identifier:

NCT01484886

First received: November 12, 2011

Last updated: February 4, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	November 12, 2011
Last Updated Date	February 4, 2013
Start Date ^ICMJE	January 2012
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 30, 2011)	oxygen utilization derived from the arterio-venous oxygen difference. [ Time Frame: 3 days ] [ Designated as safety issue: Yes ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01484886 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 30, 2011)	volume of RBC transfused [ Time Frame: 7 days ] [ Designated as safety issue: Yes ] The total numbers of RBC transfusions given during the immediate post-op period (1st 7 days) will be compared between groups.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Restrictive Versus Liberal Transfusion Protocol in Infants Undergoing Cardiac Surgery
Official Title ^ICMJE	Prospective Randomized Controlled Clinical Trial Comparing a Restrictive Versus Liberal Transfusion Strategy in Neonates and Infants Undergoing Surgery for Congenital Heart Disease
Brief Summary	In neonates and infants </= 6 months of age 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Impaired Oxygen Delivery Congenital Heart Disease
Intervention ^ICMJE	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.
Study Arm (s)	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. Intervention: Other: Red blood cell transfusion Experimental: Liberal RBC transfusion strategy RBCs will be transfused for Hemoglobin under 9.5 for biventricular repairs and under 12 for single ventricle palliations. Interventions: Other: Red blood cell transfusion Other: Red blood cell transfusion
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	100
Estimated Completion Date	August 2013
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	up to 7 Months
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01484886
Other Study ID Numbers ^ICMJE	38569
Has Data Monitoring Committee	Yes
Responsible Party	jill cholette, University of Rochester
Study Sponsor ^ICMJE	University of Rochester
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Rochester
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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