Status:
UNKNOWN
Trial Comparing Ferric(III)Carboxymaltose Infusion With Oral Iron Suppletion as Treatment of Anaemia
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Vifor Pharma
Conditions:
Anemia
Colorectal Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 color...
Detailed Description
This multicenter randomized clinical trial aims to optimize postoperative outcome in anaemic patients who undergo curative surgery for colorectal carcinoma. The aim of this trial is to investigate whi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT02243735
Start Date
November 1 2014
End Date
December 1 2019
Last Update
August 28 2018
Active Locations (13)
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1
Medisch Centrum Alkmaar
Alkmaar, Netherlands
2
Flevoziekenhuis
Almere Stad, Netherlands
3
Meander Ziekenhuis
Amersfoort, Netherlands
4
Academic Medical Center
Amsterdam, Netherlands, 1100DD