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

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.

Timeline

Start

2014-11

Primary completion

2019-11

Completion

2019-12

Publications

• Talboom K, Borstlap WAA, Roodbeen SX, Bruns ERJ, Buskens CJ, Hompes R, Tytgat KMAJ, Tuynman JB, Consten ECJ, Heuff G, Kuiper T, van Geloven AAW, Veldhuis GJ, van der Hoeven JAB, Gerhards MF, Sietses C, Spinelli A, van de Ven AWH, van der Zaag ES, Westerterp M, van Westreenen HL, Dijkgraaf ML, Juffermans NP, Bemelman WA; FIT collaborative group. Ferric carboxymaltose infusion versus oral iron supplementation for preoperative iron deficiency anaemia in patients with colorectal cancer (FIT): a multicentre, open-label, randomised, controlled trial. Lancet Haematol. 2023 Apr;10(4):e250-e260. doi: 10.1016/S2352-3026(22)00402-1. Epub 2023 Feb 27.
• Borstlap WAA, Buskens CJ, Tytgat KMAJ, Tuynman JB, Consten ECJ, Tolboom RC, Heuff G, van Geloven N, van Wagensveld BA, C A Wientjes CA, Gerhards MF, de Castro SMM, Jansen J, van der Ven AWH, van der Zaag E, Omloo JM, van Westreenen HL, Winter DC, Kennelly RP, Dijkgraaf MGW, Tanis PJ, Bemelman WA. Multicentre randomized controlled trial comparing ferric(III)carboxymaltose infusion with oral iron supplementation in the treatment of preoperative anaemia in colorectal cancer patients. BMC Surg. 2015 Jun 28;15:78. doi: 10.1186/s12893-015-0065-6.

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