Please select the eligibility criteria that correspond to the clinical trial below.
Title: An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Patients Undergoing Cardiac Surgery
Brief Summary: TRICS-III is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in high risk patients having cardiac surgery using a non-inferiority trial design.


Options:
A: Inclusion Criteria:

* Patient in the ICU AND
* Fulfil the criteria for septic shock AND
* Have haemoglobin of 9.0 g/dl (5.6 mM) or less AND
* Consent obtainable from patient or proxy or national law allows delayed consent

Exclusion Criteria:

* Documented wish against transfusion OR
* Previous serious adverse reaction with blood product OR
* Acute coronary syndrome OR
* Life-threatening bleeding OR
* RBC transfusion during current ICU admission OR
* Withdrawal from active therapy or brain death OR
* Lack of informed consent (depending on national law) OR
* Acute burn injury regardless of degree and burn surface area
B: Inclusion Criteria:

1. ≥18 and ≤65 years of age
2. Planned cardiac surgery using cardiopulmonary bypass
3. Informed consent obtained
4. Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more

Exclusion Criteria:

1. Patients who refuse participation
2. Patients who are unable to receive or who refuse blood products
3. Patients who are involved in a preoperative autologous pre-donation program
4. Patients who are having a heart transplant or having surgery solely for an insertion of a ventricular assist device
5. Pregnancy or lactation (a negative pregnancy test must be obtained prior to randomization for women of childbearing potential)
C: Inclusion Criteria:

* Provision of informed consent
* Scheduled for primary or secondary, cemented or non-cemented, total hip arthroplasty
* Classified as ASA Physical Status Classification System class P1, P2 or P3 according to the American Society of Anaesthesiology.

Exclusion Criteria:

* Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
* Previous enrollment or randomisation of treatment in the present study
* Expected or confirmed participation in another clinical study, that may interfere with the present study, during the study period
* Suspected severe non-compliance to protocol as judged by the investigator
* Current symptoms of haemophilia
* Current symptoms of hyperkalaemia
* Current symptoms of systemic infection or local infection in the operation field
* Current symptoms of impaired renal function including creatinine/clearance levels above the normal reference values
* History of or presence of malignant disease with propensity for systemic spread during the last 5 years
* Current or expected use of cytotoxic drugs
* Current untreated anaemia (e.g. sickle cell anaemia), i.e. Hb concentration \< 11 g/dl (7 mmol/l)
* Use of recombinant erythopoetin
* Use of aprotinin and/or fibrin sealant
* Use of other autologous blood transfusion than that with the Sangvia® system (e.g. CellSaver, pre-donation, acute normovolemic haemodilution etc.)
* Women of childbearing age
* Fractures
* Revision/secondary total hip surgery with expected serious bone grafting
D: Inclusion Criteria:

* Age 18 or older
* Planned cardiac surgery using cardiopulmonary bypass
* Informed consent obtained
* Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more

Exclusion Criteria:

* Patients who are unable to receive or who refuse blood products
* Patients who are involved in a preoperative autologous pre-donation program
* Patients who are having a heart transplant or having surgery solely for an insertion of a ventricular assist device
* Pregnancy or lactation (a negative pregnancy test must be obtained prior to randomization for women of childbearing potential.)
* Patients who are unable to receive or who refuse blood products

Answer: D