Please select the eligibility criteria that correspond to the clinical trial below.
Title: Red Cell Storage Duration Study
Brief Summary: The RECESS study will compare the effects of transfusing red blood cell units stored \<= 10 days vs. red blood cell units stored \>= 21 days, in patients who are undergoing complex cardiac surgery and are likely to need a red blood cell transfusion. The primary hypothesis is that there is a clinically important difference between the effects of shorter-storage red cell units and longer-storage red cell units on clinical outcomes and mortality risk.


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:

* healthy
* male body weight \>130 lbs, female body weight \> 155 lbs
* male height \>5'1", female height \>5'5"
* hemoglobin \>13.3 g/dL

Exclusion Criteria:

* ineligible for donation based on the New York Blood Center autologous blood donor questionnaire
* systolic blood pressure \>180 or \<90 mm Hg
* diastolic blood pressure \>100 or \<50 mm Hg
* heart rate \<50 or \>100
* temperature \>99.5 F prior to donation
* temperature \>100.4 F or subjective feeling of illness prior to transfusion
* positive results on standard blood donor infectious disease testing
* pregnancy.
C: Inclusion Criteria:

* Patients hospitalised in ICU with an anticipated ICU stay of at least 24 hours, in whom the decision has been made by medical staff to transfuse at least one RBC unit.

Exclusion Criteria:

* Age younger than 18
* Previous RBC transfusion during the current hospital admission (including transfusion in another hospital for transferred patients)
* Diagnosis of transplantation or hematologic diseases
* Pregnancy
* Cardiac surgery during the present hospital admission
* Expected to die imminently (\<24hrs)
* The treating physician believes it is not in the best interest of the patient to be randomised in this trial.
* Known objection to the administration of human blood products
* Participation in a competing study (see below)
D: Aim 1:

Inclusion Criteria:

* Healthy male or female volunteers (age 21-60 years)

Must meet guidelines for blood donors including:

* standard blood donor history questionnaire
* body weight of at least 110 lbs
* hemoglobin concentration of at least 12.5 gm/dL
* body temperature of no more than 99.5 oF
* pulse of 50-100 bpm
* blood pressure \< 180/100
* test negative for the standard battery of blood donor screening tests (anti-HIV, HIV RNA, anti-HCV, HCV RNA, HBsAg, anti-HBc, anti-HTLV-I/II, and WNV RNA)

Aim 1:

Exclusion Criteria:

* Failure to pass the blood donor history questionnaire
* Positive results on the standard battery of blood donor screening tests
* Failure to meet criteria for donation

Aim 2:

Inclusion Criteria:

* Healthy male or female volunteers (age 21-80 years)

Exclusion Criteria:

* Presence of intercurrent illness or other chronic diseases
* Renal failure (creatinine\>1.4 mg/dl)
* Pregnancy
* Allergies to aspirin
* Bleeding disorders
* Uncontrolled hypertension with BP \> 180 mmHg systolic and \> 120 mmHg diastolic
* Acute infection in previous 4 weeks
* History of substance abuse
* Liver failure (Liver enzymes \>2x normal)
* Inability to give informed consent
* Inability to return to Emory for follow-up

Answer: A