Please select the eligibility criteria that correspond to the clinical trial below.
Title: Standard vs. Washed Blood Cell Transfusions in Pediatric Cardiac Surgery: Impact on Post-operative Inflammation as Evidenced by the IL-6 to IL-10 Ratio.
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.


Options:
A: Inclusion Criteria:

* \>= 12 years old
* \>= 40 kg body weight
* Scheduled complex cardiac surgery with planned use of median sternotomy.
* Patients ≥ 18 years must have a Transfusion Risk Understanding Scoring Tool (TRUST) probability score ≥ 3

Exclusion Criteria:

* Refusal of blood products
* Planned surgery is minimally invasive
* Known transfusion reaction history
* Requirement for washed products, volume reduced products, or products with additive solution removed
* Expected residual cyanosis with O2 saturation \< 90
* Left ventricular assist device (LVAD) or Extracorporeal membrane oxygenation (ECMO) support pre-operatively or planned need post-operatively
* Cardiogenic shock requiring pre-operative placement of an Intra-aortic balloon pump (IABP) (IABP done for unstable angina or prophylactically for low ejection fraction is not excluded)
* Planned Deep Hypothermic Circulatory Arrest (DHCA)
* Renal dysfunction requiring pre-operative renal replacement therapies such as hemodialysis (HD) or continuous venovenous hemofiltration (CVVH)
* Planned use of alternative to heparin, e.g. bivalirudin
* Planned use of autologous or directed donations
* Prior RBC transfusion during hospitalization for the study-qualifying surgery
* Prior randomization into the RECESS study
B: 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
C: Inclusion Criteria:

* birth weight \<1000g
* postnatal age \<48 hours
* no transfusion beyond first 6 hours of life
* estimated gestational age of 30 completed weeks or less

Exclusion Criteria:

* infant considered non-viable by attending physician
* infant has cyanotic congenital heart disease
* infant's parents known to be opposed to blood transfusion
* either parent has hemoglobinopathies or congenital anemias
* infant has hemolytic disease
* infant has severe acute hemorrhage, severe shock, severe sepsis with coagulopathy or requires peri-operative transfusion
* prior treatment with or intention to treat with erythropoietin
D: Inclusion Criteria:

* Undergoing repair of ventricular septal defect within 9 months of study entry
* Tetralogy of fallot
* D-transposition of the great arteries
* Atrio-ventricular septal defect

Exclusion Criteria:

* Birth weight less than 2.3 kg
* Recognizable phenotypic syndrome of congenital anomalies
* Extracardiac anomalies of greater than minor severity
* Previous cardiac surgery
* Associated cardiovascular anomalies requiring aortic arch reconstruction or additional open surgical procedures before the planned developmental follow-up

Answer: B