Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

November 12, 2011
September 4, 2014
January 2012
September 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01484886 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Restrictive Versus Liberal Transfusion Protocol in Infants Undergoing Cardiac Surgery
Prospective Randomized Controlled Clinical Trial Comparing a Restrictive Versus Liberal Transfusion Strategy in Neonates and Infants Undergoing Surgery for Congenital Heart Disease

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Impaired Oxygen Delivery
  • Congenital Heart Disease
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
162
September 2014
September 2014   (final data collection date for primary outcome measure)

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.
Both
up to 7 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01484886
38569
Yes
jill cholette, University of Rochester
University of Rochester
Not Provided
Not Provided
University of Rochester
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP