Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase IV, Unicenter, Randomized, Double-Blind, Parallel-Group, Comparaty Study of Intravenous and Oral Iron vs Placebo in Patient Under Extracorporeal Circulation in Cardiovascular Surgery
Brief Summary: Anaemia is a common postoperative problem of cardiovascular surgery after cardiopulmonary bypass (CPB). Because of this the need for hemoderived blood transfusions is high. The purpose of this study was to compare the clinical efficacy of intravenous and oral iron in anaemia and the impact of the iron on the transfusion rate in postoperative cardiovascular surgery under extracorporeal circulation.


Options:
A: Inclusion Criteria:

* Female subjects \>/= 18 years of age
* History of Heavy uterine bleeding
* Hgb \</= 11
* Practicing acceptable birth control
* Demonstrate ability to understand and comply with protocol

Exclusion Criteria:

* Known Hypersensitivity to oral or IV iron
* Anemia other than iron deficiency anemia
* Iron storage disorders
* Initiation of treatment that may effect degree of heavy uterine bleeding
* Anticipated need for surgery
* Severe psychiatric disorder
* Active infection
* Positive Pregnancy test
* Known Hep B or C or Active Hepatitis
* Received investigational Drug within 30 days
* Alcohol or drug abuse
B: Inclusion Criteria

Non-anaemic patients treated in the FERGI-CORRECTION study (Hb ≥12 g/dL female, ≥13 g/dL male), independent of ferritin value.

Females of child-bearing potential must have a negative urine pregnancy test at screening and be practising an acceptable method of birth control during the study and for up to 1 month after the last dose of study medication.

Exclusion Criteria:

Chronic alcohol abuse (alcohol consumption \>20 g/day).

Presence of portal hypertension with oesophageal varices. History of erythropoietin, intravenous or oral iron therapy, or blood transfusion in 12 weeks prior to screening.

Known hypersensitivity to FERINJECT®.

History of acquired iron overload.

Myelodysplastic syndrome.

Pregnancy or lactation.

Known active infection, clinically significant overt bleeding, active malignancy. Known chronic renal failure.

Surgery with relevant blood loss (defined as Hb drop \<2 g/dL) in the 3 months prior to screening or planned surgery within the following 3 months.

Chronic liver disease or increase of liver enzymes (alanine aminotransferase (\[ALT\], aspartate aminotransferase \[AST\]) \>3 times the upper limit of normal range.

Known human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

Inability to fully comprehend and/or perform study procedures in the investigator's opinion.

Participation in any other interventional study (except correction study) within 1 month prior to screening.

Body weight \<35 kg.

Significant cardiovascular disease, including myocardial infarction within 12 months prior to study inclusion, congestive heart failure NYHA (New York Heart Association) grade III or IV, or poorly controlled hypertension according to the judgment of the investigator.
C: Inclusion Criteria:

* ≥21 years of age and have signed written informed consent
* Stable symptomatic CHF; NYHA III/IV and left ventricular ejection fraction (LVEF) ≤40%, or if NYHA II then LVEF must be ≤35%, as assessed within last 6 months using echocardiographic or magnetic resonance imaging techniques.
* On optimal conventional therapy for at least 4 weeks prior to recruitment and without dose changes for at least 2 weeks.
* Peak VO2 ≤ 18 ml/kg/min on modified Naughton protocol cardiopulmonary exercise testing.
* Mean of the 2 screening Hb concentrations (week-2 and week-1) \< 12.5 g/dl (anaemic group, 50% of study population) or 12.5-14.0 g/dl (non-anaemic group, 50% of study population).
* Ferritin \<100 µg/l or 100-300 µg/l with TSAT \<20%.
* Normal red cell folate and vitamin B12 status (according to local lab reference range).
* Resting blood pressure ≤160/100 mmHg.

Exclusion Criteria:

* History of acquired iron overload; known haemochromatosis or first relatives with haemochromatosis; and allergic disorders (asthma, eczema, and anaphylactic reactions).
* Known hypersensitivity to parental iron preparations.
* Known active infection, bleeding, malignancy and haemolytic anaemia.
* History of chronic liver disease and/or alanine transaminase (ALT) or aspartate transaminase (AST) \>3 times the upper limit of the normal range; chronic lung disease; myelodysplastic disorder; and known HIV/AIDS disease.
* Recipient of immunosuppressive therapy or renal dialysis.
* History of erythropoietin, IV or oral iron therapy, and blood transfusion in previous 30 days.
* Unstable angina pectoris, as judged by the investigator; severe uncorrected valvular disease or left ventricular outflow obstruction; obstructive cardiomyopathy; uncontrolled fast atrial fibrillation or flutter (heart rate \>110 beats per minute \[bpm\]); uncontrolled symptomatic brady- or tachyarrhythmias.
* Musculoskeletal limitation that, in the judgement of the investigator, would impair cardiopulmonary exercise testing.
* Pregnant or breast-feeding
* Inability to comprehend study protocol
* Parallel participation in another clinical trial
D: Inclusion Criteria:

* Men and women ≥ 18 years of age
* Patients subject to elective cardiac surgery under extracorporeal circulation
* Patients without previous anaemia, susceptible of treatment
* Patients without need of blood transfusion preoperative
* Patients providing written informed consent
* Patients who are able to complete all study visits per protocol

Exclusion Criteria:

* Patients subject to elective cardiac surgery, but without extracorporeal circulation
* Patients who were treated with fibrinolytic therapy 48 hours before the surgery
* Patients with history of impaired renal function, (e.g., calculated creatinine clearance \<50 mL/min/1.73 m2)
* Patients operated of active endocarditis
* Redo-surgery patients
* Women who are pregnant or lactating
* Patients with clinical of digestive bleeding
* Patients with vitamin B12 deficit
* Patients with ferropenic anaemia
* Patients with clinical history of asthma or allergy
* Patients with active infection
* Patients who are included in another clinical study
* Patients with hepatic disease
* Patients with history of allergy to iron
* Patients unlikely to adhere to protocol follow-up

Answer: D