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Transfusion Strategies in Pediatric Cardiothoracic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00350220
Recruitment Status : Completed
First Posted : July 10, 2006
Results First Posted : February 25, 2010
Last Update Posted : June 26, 2015
Sponsor:
Information provided by (Responsible Party):
jill cholette, University of Rochester

Tracking Information
First Submitted Date  ICMJE July 5, 2006
First Posted Date  ICMJE July 10, 2006
Results First Submitted Date  ICMJE January 19, 2010
Results First Posted Date  ICMJE February 25, 2010
Last Update Posted Date June 26, 2015
Study Start Date  ICMJE July 2006
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2010)
  • Mean Arterial Lactate Level [ Time Frame: 48 hours ]
    Mean arterial lactate for the first 48 hours post-op.
  • Peak Arterial Lactate Level [ Time Frame: 48 hours ]
    Peak arterial lactate level for the 48 hour post-op study period.
Original Primary Outcome Measures  ICMJE
 (submitted: July 5, 2006)
Mean arterial lactate level during the 8 hour to 72 hours post-operative period.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2008)
  • Oxygen Utilization During the 8 Hour to 72 Hours Post-operative Period. [ Time Frame: 3 days ]
  • Length of Mechanical Ventilation [ Time Frame: 3 days ]
  • Length of Oxygen Use [ Time Frame: 3 days ]
  • Length of Vasoactive Agent Administration [ Time Frame: 3 days ]
  • Volume of Blood Transfused [ Time Frame: 3 days ]
  • Mortality Before Hospital Discharge [ Time Frame: 30 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2006)
  • Oxygen Utilization During the 8 Hour to 72 Hours Post-operative Period.
  • Length of Mechanical Ventilation
  • Length of Oxygen Use
  • Length of Vasoactive Agent Administration
  • Volume of Blood Transfused
  • Mortality Before Hospital Discharge
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transfusion Strategies in Pediatric Cardiothoracic Surgery
Official Title  ICMJE A Prospective, Randomized, Controlled Clinical Trial Comparing Two Transfusion Strategies in Pediatric Patients Undergoing Cavopulmonary Connection.
Brief Summary The purpose of this study is to determine the best red blood cell(hemoglobin) level for infants and children following surgical repair of particular heart defects. These children often receive red blood cell transfusions after surgery, but what the best hemoglobin level is for them remains unknown.
Detailed Description

Objective: To compare mean post-operative arterial lactate levels, oxygen utilization, and outcome measures in pediatric patients undergoing cavopulmonary connection managed with two different red blood cell transfusion strategies.

Methods: We propose a prospective, randomized clinical trial of sixty-six pediatric patients with cyanotic, complex congenital cardiac disease undergoing cavopulmonary connection as their operative repair. Thirty-three patients will be randomly assigned to a low Hb strategy of transfusion, in which red cells are transfused if the hemoglobin concentration falls below 9.0 g/dL, and hemoglobin concentrations are maintained about 8.5 g/dL. Thirty-three additional patients will be randomly assigned to the high Hb transfusion strategy, where red cells are transfused if the hemoglobin concentration falls below 13.0 g/dL, and hemoglobin concentrations are maintained about 12.5 g/dL. The primary endpoint will be comparison of mean arterial lactate levels from 8 to 72 hours post-operatively. The secondary endpoints will be oxygen utilization reflected by the arterio-venous oxygen difference (AV-difference) and arterio-cerebral oxygen difference (AC-difference). Measures of oxygen utilization will be derived from arterial oxygen saturation (SaO2), mixed venous oxygen saturation (SvO2), and cerebral oxygen saturation (ScO2) collected at various time points throughout the study. Tertiary outcome measures will be length of mechanical ventilation, length of oxygen use and of vasoactive agent administration, length pediatric cardiac intensive care unit (PCICU) admission, volume of blood transfused, and mortality. Data from each group will be compared using analysis of variance to assess for the presence of a difference between the two transfusion strategies. If a significant difference between the two groups exists, T-tests will be performed to compare data points between each group to assess for a significant difference.

Hypothesis: A more restrictive (low Hb) strategy of red cell transfusion will be as effective as, and possibly superior to, the historical (high Hb) approach. Allowing a lower Hb concentration will decrease RBC donor exposure and may decrease the known complications of RBC transfusions. We postulate that no significant difference will exist between the two transfusion groups in regards to hemodynamic and cardiopulmonary status (as evidenced by mean lactate levels) and oxygen utilization.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Congenital Heart Disease
Intervention  ICMJE
  • Other: transfusion strategy
    For the High Hb group; transfusions will be given to keep the Hb >13.0 g/dl
  • Other: Low Hb transfusion group
    RBCs will not be transfused unless the Hb < 9.0 g/dl
Study Arms  ICMJE
  • Active Comparator: 1
    High Hemoglobin group; goal Hb >13g/dl. 10cc/kg RBCs are transfused for any hemoglobin value under 13g/dl regardless whether clinical indication for transfusion exists.
    Intervention: Other: transfusion strategy
  • Active Comparator: 2
    Low Hb transfusion group; goal to not transfuse unless the Hb <9.0 g/dl. 10cc/kg RBCs are transfused only if the Hemoglobin is under 9.0g/dl and clinical indications for transfusion exist.
    Intervention: Other: Low Hb transfusion group
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 Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2010)
60
Original Enrollment  ICMJE
 (submitted: July 5, 2006)
66
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 4 months to 6.99 years of age
  • surgical candidates for cavopulmonary connection
  • English speaking

Exclusion Criteria:

  • presence of known bleeding disorder
  • presence of known coagulopathy
  • age < 4 months
  • age > 7 years
  • non-English speaking
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Months to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00350220
Other Study ID Numbers  ICMJE 12408
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party jill cholette, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jill M Cholette, MD University of Rochester
PRS Account University of Rochester
Verification Date May 2015

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