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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Standard leukoreduced irradiated blood cell transfusion group |
|
| 2 | Experimental | Washed leukoreduced irradiated blood cell transfusion group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard leukoreduced irradiated blood cell transfusion | Biological | standard vs washed blood cell transfusions |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 hours post-cardiopulmonary bypass |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | post op day 1 and 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jill Cholette, MD | University of Rochester | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21926663 | Derived | Cholette JM, Henrichs KF, Alfieris GM, Powers KS, Phipps R, Spinelli SL, Swartz M, Gensini F, Daugherty LE, Nazarian E, Rubenstein JS, Sweeney D, Eaton M, Lerner NB, Blumberg N. Washing red blood cells and platelets transfused in cardiac surgery reduces postoperative inflammation and number of transfusions: results of a prospective, randomized, controlled clinical trial. Pediatr Crit Care Med. 2012 May;13(3):290-9. doi: 10.1097/PCC.0b013e31822f173c. |
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Potential subjects were recruited at pre-anesthesia inpatient assessments and outpatient pre-anesthesia appointments.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Transfusion Group | Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group |
| FG001 | Washed Transfusion Group | Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Transfusion Group | Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group |
| BG001 | Washed Transfusion Group | Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Median | Standard Error | ratio | 12 hours post-cardiopulmonary bypass |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Transfusion Group | Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jill M. Cholette MD, Principle Investigator | University of Rochester | 585-275-8138 | Jill_Cholette@urmc.rochester.edu |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| Washed leukoreduced irradiated blood cell transfusions | Biological | washed leukoreduced irradiated blood cell transfusions |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Washed Transfusion Group | Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group |
|
|
| 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 | 64 subjects in each group that received blood; all included in the analysis | Posted | Median | Full Range | mg/dL | post op day 1 and 2 |
|
|
|
|
| 6 |
| 81 |
| 13 |
| 81 |
| EG001 | Washed Transfusion Group | Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group | 2 | 81 | 13 | 81 |
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
for POD#2 assessment |
| Other |