Transfusion Strategies in Pediatric Cardiothoracic Surgery

This study has been completed.
Sponsor:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00350220
First received: July 5, 2006
Last updated: February 11, 2010
Last verified: January 2010

July 5, 2006
February 11, 2010
July 2006
September 2009   (final data collection date for primary outcome measure)
  • Mean Arterial Lactate Level [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Peak Arterial Lactate Level [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Mean arterial lactate level during the 8 hour to 72 hours post-operative period.
Complete list of historical versions of study NCT00350220 on ClinicalTrials.gov Archive Site
  • Oxygen Utilization During the 8 Hour to 72 Hours Post-operative Period. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Length of Mechanical Ventilation [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Length of Oxygen Use [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Length of Vasoactive Agent Administration [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Volume of Blood Transfused [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Mortality Before Hospital Discharge [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • 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
Not Provided
Not Provided
 
Transfusion Strategies in Pediatric Cardiothoracic Surgery
A Prospective, Randomized, Controlled Clinical Trial Comparing Two Transfusion Strategies in Pediatric Patients Undergoing Cavopulmonary Connection.

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Congenital Heart Disease
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
4 Months to 7 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00350220
12408
Not Provided
Jill M. Cholette MD, URMC
University of Rochester
Not Provided
Principal Investigator: Jill M Cholette, MD University of Rochester
University of Rochester
January 2010

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