Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Two Hemoglobin Thresholds for Transfusion in Newborns <1000g Birth Weight
Brief Summary: Hypothesis: That a high hemoglobin threshold for transfusion in extremely low birth weight (ELBW) infants is associated with a lower rate of survival without severe morbidity (defined as one or more of retinopathy of prematurity, bronchopulmonary dysplasia, or periventricular leukomalacia/ventriculomegaly).

Primary Objective: To determine whether either a liberal or more restrictive threshold of hemoglobin level for red cell transfusion in ELBW infants is safer, by randomizing to either a high transfusion hemoglobin threshold or a low transfusion hemoglobin threshold.

Follow-up at a corrected age of 18 months represents a conventional age at which to first assess neurodevelopmental outcomes, and to predict long-term outcomes.


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:

* birthweight of less than 1250g
* admitted to participating NICU
* consent acquired from proxy for the patient

Exclusion Criteria:

* already received one or more transfusions
* requirement for an exchange transfusion
* will be receiving directed donations
* have rare blood types/difficult cross-match
* proxy has refused consent
* moribund on admission to NICU/expected to die
* mitigating child protection issues
C: 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
D: 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

Answer: D