Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Double-Blind Safety Comparison of Intravenous Iron Dextran Versus Iron Sucrose in an Adult Non-Hemodialysis Outpatient Population: A Pilot Study
Brief Summary: The purpose of this trial is to compare the safety profile using equal doses of intravenous iron dextran versus iron sucrose. The researchers hypothesize that significantly more patients receiving intravenous iron dextran (using the current intermediate molecular weight product) will have severe adverse outcomes than patients receiving iron sucrose in the adult non-hemodialysis outpatient population. Secondly, since these severe reactions may require additional nursing time and physician interventions that may negate any cost advantage of iron dextran, the researchers hypothesize that iron sucrose will be more cost-effective than iron dextran.


Options:
A: Inclusion Criteria:

* Iron deficient subjects with stable chronic heart failure (CHF) (NYHA II-III) on optimal background therapy for CHF
* Reduced exercise capacity
* Reduced left ventricular ejection fraction
* At least 18 years of age and with written informed consent prior to any study specific procedures

Exclusion Criteria:

* Erythropoietin stimulating agent (ESA) use, IV iron therapy, and/or blood transfusion in previous 6 weeks prior to randomisation
* Exercise training program(s) in the 3 months prior to screening or planned in the next 6 months
* Chronic liver disease and/or elevated liver enzymes
* Vitamin B12 and/or serum folate deficiency
* Subject is not using adequate contraceptive precautions during the study
* No other significant cardiac or general disorder that would compromise participation in the study
B: Inclusion criteria:

* Patients undergoing valve- and/or coronary bypass surgery
* Signed patient informed consent
* Only patients will be enrolled who won't have an emergency surgery on the same day

Exclusion criteria:

* Participation in another clinical trial within the last 4 weeks prior to enrollment
* Addiction or other disease that did not allow the patient to assess the nature, scope and possible consequences of the clinical tial
* Patients who do not sign the consent form or may not fully understand from inadequate knowledge of German.
* Patients who have not reached the age of legal majority
* Pregnant or lactating women
* Jehovah's Witnesses
* Patients with endocarditis
* Existing allergy or intolerance to ferric carboxymaltose or mannitol
C: Inclusion Criteria:

* Age 18 to 100
* To be receiving intravenous iron

Exclusion Criteria:

* Age \< 18
* Hemodialysis
* Previous exposure to intravenous iron
* Unable to provide written consent
D: Inclusion Criteria:

* Female, 18 to 45 years old,
* Serum Ferritin levels \<20 µg/L,
* Normal body Mass Index (18.5-25 kg/m2),
* Body weight \<65 kg,
* Signed informed consent

Exclusion Criteria:

* Anaemia (Hb \< 11.7 g/dL),
* Elevated c-reactive protein or alpha1 glycoprotein concentrations \>5.0 mg/L, \>1.0 g/L, respectively,
* Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement),
* Continuous/long-term use of medication during the whole studies (except for contraceptives),
* Consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement administration,
* Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months,
* Earlier participation in a study using stable iron isotopes,
* Known hypersensitivity or allergy to iron supplements,
* Women who are pregnant or breast feeding,
* Intention to become pregnant during the course of the studies,
* Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the studies, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Participation in another study with investigational drug within the 30 days preceding and during the present studies,
* Enrolment of the investigator, his/her family members, employees and other dependent persons

Answer: C