Congenital Heart Disease
Conditions
Keywords
pediatrics, congenital heart disease
Brief summary
Background: Children having open heart surgery to repair congenital heart defects demonstrate a large inflammatory response to the heart-lung machine and to surgery itself. In general, the more intense their inflammatory response, the more critically ill they are following surgery. These children routinely require large numbers of blood transfusions during and following surgery as part of their medical management that adds to their heightened inflammatory state. Whether additional steps to wash blood products and remove the substances contributing to post-transfusion inflammation will limit this response, and improve the health of children following open heart surgery, remains to be studied. Aims: To compare the inflammatory response in children having open heart surgery who receive washed versus unwashed blood transfusions. Methods: We will randomly assign children having open heart surgery to one of two groups: group 1 will receive blood transfusions per the current standard of care, group 2 will receive blood transfusions that have been washed in addition to the current standard of care. We will then use blood tests to measure the inflammatory response in children of each group. We will compare the results to determine whether washing blood transfusions decreases inflammation and post-operative complications following open heart surgery. Conclusion: We believe that washing blood transfusions given to children following open heart surgery will decrease their inflammatory response and improve their overall health.
Interventions
BIOLOGICALStandard leukoreduced irradiated blood cell transfusion
standard vs washed blood cell transfusions
BIOLOGICALWashed leukoreduced irradiated blood cell transfusions
washed leukoreduced irradiated blood cell transfusions
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
Inclusion criteria
1. age \< 18 years 2. surgical repair at URMC by the pediatric cardiac surgical team 3. informed consent signed by the parent or legal guardian, and if applicable, assent obtained from the subject.
Exclusion criteria
1. Age ≥18 years 2. inability to provide consent/assent; 3) subjects having emergent surgical procedures. Subjects with chronic inflammatory or autoimmune disorders will not be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12 Hour Plasma Interleukin (IL)-6 to IL-10 Ratio | 12 hours post-cardiopulmonary bypass | plasma was obtained pre-op, immediately once off cardiopulmonary bypass (CPB), six hours following CPB and 12 hours following CPB. The plasma was centrifuged and the supernatant collected and stored at -70 degrees. The samples then underwent Luminex testing for IL-6 and IL-10 levels, and the IL-6:IL-10 ratio was calculated (IL-6 being the numerator and IL-12 being the denominator). The 12 hour ratio was the primary outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median wrCRP Level | post op day 1 and 2 | wide range C reactive protein levels were obtained before surgery (pre-operatively) and on post-operative day 1 and 2 in transfused subjects |
Participant flow
Recruitment details
Potential subjects were recruited at pre-anesthesia inpatient assessments and outpatient pre-anesthesia appointments.
Participants by arm
| Arm | Count |
|---|---|
| Standard Transfusion Group Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group | 81 |
| Washed Transfusion Group Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group | 81 |
| Total | 162 |
Baseline characteristics
| Characteristic | Washed Transfusion Group | Standard Transfusion Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 81 Participants | 81 Participants | 162 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 Age | 1 days | 1 days | 1 days |
| Sex: Female, Male Female | 18 Participants | 17 Participants | 35 Participants |
| Sex: Female, Male Male | 63 Participants | 64 Participants | 127 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 81 | 13 / 81 |
| serious Total, serious adverse events | 6 / 81 | 2 / 81 |
Outcome results
Primary
12 Hour Plasma Interleukin (IL)-6 to IL-10 Ratio
plasma was obtained pre-op, immediately once off cardiopulmonary bypass (CPB), six hours following CPB and 12 hours following CPB. The plasma was centrifuged and the supernatant collected and stored at -70 degrees. The samples then underwent Luminex testing for IL-6 and IL-10 levels, and the IL-6:IL-10 ratio was calculated (IL-6 being the numerator and IL-12 being the denominator). The 12 hour ratio was the primary outcome measure.
Time frame: 12 hours post-cardiopulmonary bypass
Population: Only data from those subjects receiving transfusions was analyzed as the study intervention was the type of red blood cell and platelet transfusion (washed v. unwashed).
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Standard Transfusion Group | 12 Hour Plasma Interleukin (IL)-6 to IL-10 Ratio | 8.9 ratio | Standard Error 1.2 |
| Washed Transfusion Group | 12 Hour Plasma Interleukin (IL)-6 to IL-10 Ratio | 3.8 ratio | Standard Error 1.3 |
Secondary
Median wrCRP Level
wide range C reactive protein levels were obtained before surgery (pre-operatively) and on post-operative day 1 and 2 in transfused subjects
Time frame: post op day 1 and 2
Population: 64 subjects in each group that received blood; all included in the analysis
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard Transfusion Group | Median wrCRP Level | POD #1 | 43 mg/dL |
| Standard Transfusion Group | Median wrCRP Level | POD #2 | 70 mg/dL |
| Washed Transfusion Group | Median wrCRP Level | POD #1 | 38 mg/dL |
| Washed Transfusion Group | Median wrCRP Level | POD #2 | 59 mg/dL |
p-value: <0.03Wald Wolfowitz
p-value: 0.29Wald-Wolf