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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
  Purpose

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.


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:

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.


Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01484886

Locations
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Jill M Cholette, MD     585-275-0189     Jill_Cholette@urmc.rochester.edu    
Principal Investigator: Jill M Cholette, MD            
Sponsors and Collaborators
University of Rochester
  More Information

No publications provided

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: February 4, 2013
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 May 16, 2013