Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2025-12-24 @ 10:15 PM
NCT ID:
NCT02243735
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02243735
Study Brief:
Protocol Section:
NCT02243735