CompletedPhase 4ACTRN12614001261606

Assessment of a single intravenous iron infusion versus standard care in the management of Post-OPerative Iron (POPi) deficiency anaemia patients undergoing elective surgery at the Launceston General Hospital

Intravenous ferric carboxymaltose versus standard care in the management of postoperative anaemia: A prospective randomised controlled trial


Sponsor

University of Tasmania

Enrollment

200 participants

Start Date

Dec 15, 2014

Study Type

Interventional

Conditions

Summary

Since 2007, we have conducted several studies assessing preoperative anaemia in different settings including elective surgery. We noted that there was an inherent delay in the management of preoperative anaemia with most of these patients proceeding with the planned surgery without having their iron deficiency anaemia addressed. Despite the improvement in preoperative management, it has been found that there are a significant, although unknown number of patients who have postoperative iron deficiency anaemia. Furthermore, there is lack of data regarding prevalence of postoperative iron deficiency anaemia or amount of blood transfusions in patients who undergo elective surgery. Hence the importance of this trial to study all of these factors in Tasmanian patients attending the Launceston General Hospital in order to provide a pragmatic solution to this problem of postoperative anaemia. This study is aiming to recruit patients with iron defciency anaemia and to then randomise them between administration of a single intravenous iron carboxymaltose and standard care. Participants will be followed up by the research assistant from the time of recruitment/randomisation until 3 months post-operatively. This allows for the completion of a questionnaire regarding their wellbeing at the time, outcome of trial medications, and blood tests as required. In summary, this study is dealing with an important problem, post-operative anaemia after surgery patients, an issue that to date has not been addressed by our health system, and which is usually significantly increased in this group of patients. This trial is focusing on treating postoperative anaemia adequately to minimize risk factors of anaemia and to avoid blood transfusion and hence its subsequent complications/hazards. Another possible benefit of this trial is that it will help to relieve the current shortage of blood supply from the Red Cross. We also aim to minimize the patient’s stay in hospital and improve their quality of life. Iron infusion would be performed in the LGH utilising the currently available facilities. The newly available iron infusion (15 min) is part of standard therapy and is routinely performed in this area without adding extra load to the system.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

  • Patients who undergoing elective surgery with Hb >120 g/L will serve as control group.

Exclusion Criteria2

  • Presence of a specific cause for anaemia apart from haematinic deficiency
  • Patients with active infection and or sepsis

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Interventions

Patients with post-operative anaemia will be randomised between standard care after surgery and a single iron carboxymaltose infusion 15mg/Kg body weight once only infused over 15 minutes within 24-48

Patients with post-operative anaemia will be randomised between standard care after surgery and a single iron carboxymaltose infusion 15mg/Kg body weight once only infused over 15 minutes within 24-48 hours post-operatively.


Locations(1)

TAS, Australia

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ACTRN12614001261606