Restrictive Versus Liberal Transfusion Protocol in Infants Undergoing Cardiac Surgery

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

jill cholette, University of Rochester

ClinicalTrials.gov Identifier:

NCT01484886

First received: November 12, 2011

Last updated: September 4, 2014

Last verified: September 2014

History of Changes

Purpose

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	Intervention
Impaired Oxygen Delivery Congenital Heart Disease	Other: Red blood cell transfusion


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Blood Transfusion and Donation Heart Diseases Heart Surgery

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.


Enrollment:	162
Study Start Date:	January 2012
Study Completion Date:	September 2014
Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


Ages Eligible for Study:	up to 7 Months (Child)
Genders Eligible for Study:	Both
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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Please refer to this study by its ClinicalTrials.gov identifier: 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


Responsible Party:	jill cholette, Assistant Professor of Pediatrics, University of Rochester
ClinicalTrials.gov Identifier:	NCT01484886 History of Changes
Other Study ID Numbers:	38569
Study First Received:	November 12, 2011
Last Updated:	September 4, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on September 27, 2016

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