Trial Comparing Ferric(III)Carboxymaltose Infusion With Oral Iron Suppletion as Treatment of Anaemia

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this multicenter trial is to determine the efficacy of preoperative intravenous iron suppletion in comparison with the standard preoperative oral substitution in anaemic patients with colorectal cancer in curing the anemia and the assess the effect of preoperative iron on morbidity, postoperative recovery and quality of life.

Hypothesis: It is our hypothesis that a more profound approach of preoperative anaemia with intravenous iron will lead to a higher percentage of patients with normalization of Hb-level (> 12 g/dl (7.5 mmol/l) for women and > 13 g/dl (8 mmol/l) for men), which potentially reduces morbidity, length of stay, improves quality of live, decreases fatigue and could be more cost effective compared to current practice with oral substitution of iron.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborator: Vifor Pharma
• Treatments: Ferrous fumarate

Criteria

Inclusion Criteria:

• M0-stage Colorectal carcinoma

• Laparoscopic or open segmental colonic resection or (low) anterior resection

• Iron deficiency anaemia: Hb <7,5 mmol/l (12 g/dl) for women and Hb < 8 mmol/l (13 g/dl) for men and TSAT<20%

• Age 18 or older

• Written informed consent for study participation

Exclusion Criteria:

• Palliative surgery / metastasized disease

• Received blood transfusion within one month before screening

• Serum ferritin ≥ 800 µg/L

• Pregnancy

• Preoperative chemoradiation (Short course radiotherapy (5x5 Gy) = no exclusion)

• Contraindication for the use of ferric(III)carboxymaltose or ferrofumarate

• ASA classification > 3

• Use of erythropoietin stimulating agents within three months before screening

• Chronic kidney disease (GFR < 30ml/min/m)

• Myelodysplastic syndrome

• Severe anaemia with indication for blood transfusion

• Elevated liver enzymes (more than three times normal value)

• Hereditary Hemochromatosis

• Thalassemia

• Haemolytic anaemia/ chronic haemolysis