Postoperative i.v. Iron Substitution in Patients With Diagnosed Iron Deficiency

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Iron deficiency anaemia (IDA) in postoperative patients with confirmed preoperative iron deficiency (ID) in a population with planned major surgery who need fast replenishment of iron as judged by the treating physician will be treated with i.v. iron using Polyglucoferron, Ferric Carboxymaltose or oral iron

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Frank Behrens
• Collaborators: IRON4U; University Hospital Frankfurt Institute for Biostatistics & Mathematical Modelling; University Hospital Frankfurt, Department of Anaesthesiology
• Treatments: Ferric Compounds

Criteria

Inclusion Criteria:

• Males or female; aged ≥ 18 years

• Patients after major surgery (e.g., orthopaedic/trauma, vascular, visceral, cardiac surgery) with risk of Hb reduction and/or blood loss who develop anaemia defined as haemoglobin of <12 g/dL for female and <13 g/dL for men within 12 to 72 h after start of surgery and with confirmation at Baseline

• Confirmed and documented preoperative iron deficiency defined as S-ferritin <100 ng/mL without anaemia (Hb ≥12 g/dL for female and ≥13 g/dL for male) within 28 days before surgery

• need for fast iron replenishment as judged by the treating physician

• Written informed consent; willing/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 physical inability, e.g., American society of anesthesiologists (ASA) physical status IV or V

• Patients receiving blood transfusion 24 week prior surgery

• 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 main study period

• Patients with hemodynamic instability due to any ongoing bleeding. Absence of ongoing bleeding will be confirmed determined either by decision of two independent physicians or by removal of drainage, whichever occurs earlier in routine care)

• Patients with any contraindication to the investigational products, e.g.,

1. known sensitivity to iron or an ingredient of the investigational products

2. Significant history of systemic allergic reactions

3. Haemachromatosis, thalassemia or TSAT >50% as indicator of iron overload

4. Acute or chronic intoxication

5. Infection (patient on non-prophylactic antibiotics)

6. 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

• 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

1. according to Summary of product characteristics (SmPC)

2. hypersensitivity to any ingredient in the formulation

3. concomitant parenteral iron

4. haemochromatosis, and other iron overload syndromes

• Exclusion criteria related to Ferric Carboxymaltose:

1. according to Summary of product characteristics (SmPC)

2. hypersensitivity to the active substance, to Ferric Carboxymaltose or any of its excipients

3. known serious hypersensitivity to other parenteral iron products

4. anaemia not attributed to iron deficiency

5. evidence of iron overload or disturbances in the utilisation of iron

• Exclusion criteria related to Polyglucoferron

1. hypersensitivity to any ingredient in the formulation

2. known serious hypersensitivity to other parenteral iron products

3. anaemia not attributed to iron deficiency

4. evidence of iron overload or disturbances in the utilisation of iron