Congenital Heart Disease
Conditions
Keywords
Single ventricle, Bidirectional Glenn, Fontan, Congenital cardiac disease, Red blood cell transfusion, oxygen utilization, lactate level, hemoglobin level
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.
Interventions
OTHERtransfusion strategy
For the High Hb group; transfusions will be given to keep the Hb \>13.0 g/dl
OTHERLow Hb transfusion group
RBCs will not be transfused unless the Hb \< 9.0 g/dl
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Months to 7 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Arterial Lactate Level | 48 hours | Mean arterial lactate for the first 48 hours post-op. |
| Peak Arterial Lactate Level | 48 hours | Peak arterial lactate level for the 48 hour post-op study period. |
Secondary
| Measure | Time frame |
|---|---|
| Length of Oxygen Use | 3 days |
| Length of Vasoactive Agent Administration | 3 days |
| Oxygen Utilization During the 8 Hour to 72 Hours Post-operative Period. | 3 days |
| Mortality Before Hospital Discharge | 30 days |
| Volume of Blood Transfused | 3 days |
| Length of Mechanical Ventilation | 3 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High Hemoglobin (Liberal) Group High Hemoglobin group; goal Hb \>13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion. | 30 |
| Low Hb (Restrictive) Group Low Hb transfusion group; RBCs are not transfused unless the Hb \<9.0 g/dl and clinical indications for transfusion are met. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Low Hb (Restrictive) Group | High Hemoglobin (Liberal) Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 30 Participants | 30 Participants | 60 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 2.25 years STANDARD_DEVIATION 1.8 | 2.75 years STANDARD_DEVIATION 1.9 | 2.5 years STANDARD_DEVIATION 1.8 |
| Region of Enrollment United States | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 13 Participants | 13 Participants | 26 Participants |
| Sex: Female, Male Male | 17 Participants | 17 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Mean Arterial Lactate Level
Mean arterial lactate for the first 48 hours post-op.
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Hemoglobin (Liberal) Group | Mean Arterial Lactate Level | 1.4 mmol/L | Standard Deviation 0.4 |
| Low Hb (Restrictive) Group | Mean Arterial Lactate Level | 1.4 mmol/L | Standard Deviation 0.5 |
Primary
Peak Arterial Lactate Level
Peak arterial lactate level for the 48 hour post-op study period.
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Hemoglobin (Liberal) Group | Peak Arterial Lactate Level | 3.2 mmol/l | Standard Deviation 1.3 |
| Low Hb (Restrictive) Group | Peak Arterial Lactate Level | 3.1 mmol/l | Standard Deviation 1.5 |
Secondary
Length of Mechanical Ventilation
Time frame: 3 days
Secondary
Length of Oxygen Use
Time frame: 3 days
Secondary
Length of Vasoactive Agent Administration
Time frame: 3 days
Secondary
Mortality Before Hospital Discharge
Time frame: 30 days
Secondary
Oxygen Utilization During the 8 Hour to 72 Hours Post-operative Period.
Time frame: 3 days
Secondary
Volume of Blood Transfused
Time frame: 3 days