Clinical trial NCT00350220: Transfusion Strategies in Pediatric Cardiothoracic Surgery
Official title: A Prospective, Randomized, Controlled Clinical Trial Comparing Two Transfusion Strategies in Pediatric Patients Undergoing Cavopulmonary Connection.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Congenital Heart Disease
Keywords: Single ventricle
Bidirectional Glenn
Fontan
Congenital cardiac disease
Red blood cell transfusion
oxygen utilization
lactate level
hemoglobin level
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2006-07-10
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Arterial Lactate Level
timeFrame: 48 hours
measure: Peak Arterial Lactate Level
timeFrame: 48 hours
Secondary outcomes:
measure: Oxygen Utilization During the 8 Hour to 72 Hours Post-operative Period.
timeFrame: 3 days
measure: Length of Mechanical Ventilation
timeFrame: 3 days
measure: Length of Oxygen Use
timeFrame: 3 days
measure: Length of Vasoactive Agent Administration
timeFrame: 3 days
measure: Volume of Blood Transfused
timeFrame: 3 days
measure: Mortality Before Hospital Discharge
timeFrame: 30 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Jill M Cholette, MD
role: PRINCIPAL_INVESTIGATOR
References: