Transfusion Strategies in Pediatric Cardiothoracic Surgery
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): transfusion strategy; Low Hb transfusion group
Intervention type(s): Other; Other
Intervention description(s): For the High Hb group; transfusions will be given to keep the Hb >13.0 g/dl; RBCs will not be transfused unless the Hb < 9.0 g/dl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Single ventricle; Bidirectional Glenn; Fontan; Congenital cardiac disease; Red blood cell transfusion; oxygen utilization; lactate level; hemoglobin level