Polyglucoferron Compared to i.v. Ferric Carboxymaltose and Oral Iron Substitution in Preoperative Treatment of Iron Deficiency Anaemia in Patients (IDA-I)
Iron Deficiency Anemia
About this trial
This is an interventional treatment trial for Iron Deficiency Anemia focused on measuring pre surgery iron treatment
Eligibility Criteria
Inclusion Criteria:
- Male or female; aged ≥ 18 years
- Planned to undergo non-cardiac surgery (e.g., orthopaedic, vascular, visceral surgery) within 28 to 42 days, which requires a fast replenishment of the patients' iron stores (e.g.if it is not appropriate to postpone surgery) as judged by the treating physician
- Iron deficiency defined as s-ferritin <100 ng/mL and s-transferrin saturation <20%
- Relevant anaemia defined as haemoglobin of <12 g/dL for female and <13 g/dL for men
- Written informed consent; willing and able to comply with the protocol
Exclusion Criteria:
- Pregnancy in female patients or breastfeeding women
- Female patients not willing to use a safe method of contraception (PEARL index <1) for the full study period
- Severe anaemia with Hb < 8 g/dL
- Any ingoing bleeding as judged by the treating physician
- Patients receiving blood transfusion 24 weeks prior screening
- Severe physical inability, e.g., American Society of Anesthesiologists (ASA) physical status IV or V
- Haematuria and proteinuria of unknown or known origin
- Non-iron deficiency anaemia, e.g., known Vitamin B12 or folate deficiency, haemoglobinopathy, or unexplained anaemia
- Anticipated medical need for erythropoiesis-stimulating agents during the study period
Patients with any contraindication to the investigational products, e.g.,
- known sensitivity to iron or an ingredient of the investigational products
- History of systemic allergic reactions
- Haemachromatosis, thalassemia or TSAT >50% as indicator of iron overload
- Acute or chronic intoxication
- Infection (patient on non-prophylactic antibiotics)
- Chronic liver disease and/or screening Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) above three times the upper limit of the normal range
- Chronic kidney disease, defined as Glomerular Filtration Rate (GFR) <30 mL/min
- Serum Creatinine > 150 μmol/L
- Active uncontrolled immune-mediated diseases such as rheumatoid arthritis or inflammatory bowel disease
- Primary haematologic disease
- Drug or alcohol abuse according to WHO definition
- Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study
- Current or previous participation in another clinical trial during the last 90 days before screening
Exclusion criteria related to Ferrous sulfate
- according to summary of product characteristics (SmPC)
- hypersensitivity to any ingredient in the formulation
- concomitant parenteral iron
- haemochromatosis, and other iron overload syndromes
Exclusion criteria related to Ferric Carboxymaltose:
- according to SmPC
- hypersensitivity to the active substance, to Ferinject or any of its excipients
- known serious hypersensitivity to other parenteral iron products
- anaemia not attributed to iron deficiency
- evidence of iron overload or disturbances in the utilisation of iron
Exclusion criteria related to Polyglucoferron f) hypersensitivity to any ingredient in the formulation
- known serious hypersensitivity to other parenteral iron products
- anaemia not attributed to iron deficiency
- evidence of iron overload or disturbances in the utilisation of iron
Sites / Locations
- Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital of Goethe-University
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
Polyglucoferron
Ferric Carboxymaltose
Ferrous sulfate
once intravenously, dosing according to Hb-levels and body weight, 500 - 2000 mg
Once intravenously (a second administration is allowed), dosing according to Hb-levels and body weight (500 - 2000 mg, max. single dose of 1000 mg)
capsules, orally, dosing 50 mg - 200 mg (50 mg: 1 capsule in total, 200 mg: 4 capsules in total, taken as 2 capsules twice daily), duration of treatment 28 days