Abstract

Efficacy of Ferrous Bisglycinate Chelate for the Management of Preoperative Anaemia in Orthopaedic Surgical Patients: A Prospective Study

Maria Beatrice Rondinelli, Giovanni Inghilleri, Marco Pavesi, Antonella Di Bartolomei, Roberta Pagnotta, Daniela Fioravanti, Paola Iudicone, Sandro Rossetti, Francesco Pallotta, Marco Bertini and Luca Pierelli

Background: Oral iron support in patients (pts) undergoing preoperative autologous blood donation (PABD) programs has been suggested by different authors to improve red blood cell (RBC) production and limit iron depletion. Oral iron therapy, however, is frequently associated with side effects and poor pts compliance. The aim of this study was to evaluate the effectiveness of low doses of ferrous bisglycinate chelate (Tecnofer, Baldacci) a new oral iron preparation characterized by high gastrointestinal absorption and tolerability in the management of preoperative anemia.

Material and methods: In our hospital we used a multimodal approach of integrated alternatives strategies after a preliminary clinical evaluation (CE) that provides a supportive iron therapy. We enrolled 60 pts candidate for orthopedic surgery presenting hemoglobin (Hb) levels between 11.5 and 12.5 g/dL in order to evaluate the effectiveness of ferrous bisglycinate chelate for these pts who presented gastrointestinal side effects related to previous oral iron treatment. All pts pre-deposited 1 unit of PABD (400 mL) at day 0. Forty pts (Group A) received 1 tablet/day of ferrous bisglicinate (14 mg/day) for 10 days. No iron was given to 20 pts (Group B). The variation in Hb concentration, percentage of reticulocytes (% RET), serum ferritin (FER) and percentage of transferrin saturation (%SAT) from the day of pre-deposit to ten days after donation were compared between the two groups.

Results: The study lasted From October 2014 to December 2014 baseline Hb, RET count, serum FER and transferrin saturation were similar in the 2 groups. Pts receiving iron therapy had a lesser iron depletion, an increased erythropoiesis which in turn limited Hb reduction due to PABD, without showing any side effects.

Discussion: Preliminary data of our study seem to indicate that oral administration of low doses of ferrous bisglycinate chelate is an effective and safe therapy to support PABD and to treat iron deficiency in patient’s candidate for major surgery. The high patient’s compliance to this new oral iron therapy seems to be a “Key Factor” in the treatment success.