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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614001261606
Acronym
Post-OPerative Iron deficiency anaemia trial (POPi)
Enrollment
201
Registered
2014-12-03
Start date
2014-12-15
Completion date
2015-05-07
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 hours post-operatively.

Sponsors

University of Tasmania
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

The inclusion criteria for anaemic patients who undergoing elective surgery in the study will be a haemoglobin level equal or above 70 g/L, but < 120 g/L as measured by an accredited LGH pathology laboratory in addition to low iron stores and or low iron saturation equal or <20%. Patients who undergoing elective surgery with Hb >120 g/L will serve as control group.

Exclusion criteria

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

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 12, 2026