Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00350220
Status:
COMPLETED
Last Update Posted:
2015-06-26
First Post:
2006-07-05
Brief Title:
Transfusion Strategies in Pediatric Cardiothoracic Surgery
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
A Prospective Randomized Controlled Clinical Trial Comparing Two Transfusion Strategies in Pediatric Patients Undergoing Cavopulmonary Connection
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the best red blood cellhemoglobin 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 90 gdL and hemoglobin concentrations are maintained about 85 gdL 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 130 gdL and hemoglobin concentrations are maintained about 125 gdL 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
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 90 gdL and hemoglobin concentrations are maintained about 85 gdL 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 130 gdL and hemoglobin concentrations are maintained about 125 gdL 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None