Feasibility of conducting a randomized controlled trial to explore the muscular influence of post-operative intravenous iron treatment for anaemia after major abdominal surgery.
Beth MacLean, Robert U Newton, Jayne Lim, Toby Richards
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Abstract
Background and objectives: Iron deficiency anaemia is common in patients recovering from major surgery and is associated with poorer post-operative outcomes. We designed a randomized controlled trial treating post-operative anaemia with iron therapy to observe the influence on post-operative recovery.
Materials and methods: Anaemic patients (haemoglobin [Hb] < 120 g/L for women, Hb < 130 g/L for men) recovering from major abdominal surgery at Fiona Stanley Hospital were recruited. Patients were double-blind randomized 1:1 to ferric carboxymaltose (FCM) or saline administered 4 weeks post-discharge and included in a 12-week exercise programme. Iron indices, quality of life (QoL) questionnaires and muscle function tests were conducted at 4 weeks (baseline), 8-, 12- and 16-weeks post-discharge. This pilot study primarily aimed to assess the feasibility of recruiting 20 patients per intervention arm.
Trial registration: ACTRN12622001447741.
Results: Of 205 eligible patients screened between 5 May 2023 and 31 August 2023, only four patients were recruited, of which one completed the study. After randomization to FCM, results obtained from the sole participant that completed the trial suggested a trend towards improvement in QoL outcomes, Hb and muscle function.
Conclusion: Recruitment to a randomized controlled trial exploring the influence of iron therapy on muscle function after major abdominal surgery was not feasible.
期刊介绍：
Vox Sanguinis reports on important, novel developments in transfusion medicine. Original papers, reviews and international fora are published on all aspects of blood transfusion and tissue transplantation, comprising five main sections:
1) Transfusion - Transmitted Disease and its Prevention:
Identification and epidemiology of infectious agents transmissible by blood;
Bacterial contamination of blood components;
Donor recruitment and selection methods;
Pathogen inactivation.
2) Blood Component Collection and Production:
Blood collection methods and devices (including apheresis);
Plasma fractionation techniques and plasma derivatives;
Preparation of labile blood components;
Inventory management;
Hematopoietic progenitor cell collection and storage;
Collection and storage of tissues;
Quality management and good manufacturing practice;
Automation and information technology.
3) Transfusion Medicine and New Therapies:
Transfusion thresholds and audits;
Haemovigilance;
Clinical trials regarding appropriate haemotherapy;
Non-infectious adverse affects of transfusion;
Therapeutic apheresis;
Support of transplant patients;
Gene therapy and immunotherapy.
4) Immunohaematology and Immunogenetics:
Autoimmunity in haematology;
Alloimmunity of blood;
Pre-transfusion testing;
Immunodiagnostics;
Immunobiology;
Complement in immunohaematology;
Blood typing reagents;
Genetic markers of blood cells and serum proteins: polymorphisms and function;
Genetic markers and disease;
Parentage testing and forensic immunohaematology.
5) Cellular Therapy:
Cell-based therapies;
Stem cell sources;
Stem cell processing and storage;
Stem cell products;
Stem cell plasticity;
Regenerative medicine with cells;
Cellular immunotherapy;
Molecular therapy;
Gene therapy.
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