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

Phase 4

Completed

• Conditions: post-operative iron deficiency anaemia; Blood - Anaemia; Surgery - Other surgery

• Registration Number: ACTRN12614001261606
• Lead Sponsor: niversity of Tasmania

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of IV iron in postoperative anaemia setting<br><br>Tools: Via full blood count with measurement of Haemoglobin (Hb) and assay of serum iron studies measurement <br>[this timepoint will be measured at discharge, 4 weeks and at the end of the study at 3 months. ];To assess blood transfusion requirement in both groups of patients.[Number of transfused blood units /Amount of blood until discharge ];To assess the prevalence of postoperative iron deficiency anaemia among patients who present to the LGH for elective surgery by recording all anaemic patients versus total number of surgery on the specified trial period. [until the end of study approx 18 months]

Secondary Outcome Measures

Name	Time	Method
To assess drug safety, and tolerability by a specially designed tolerability assessment form conducted by the treating medical staff during the admission . [until patient discharge ];patient outcome in termms of recovery postoperatively.<br><br>Parameters to be assessed via Postoperative Recovery Profile (PRP), alive status and overall performance at discharge.[ by patients discharge.];To assess effect on quality of life with SF-36 Quality of Life Questionnaire[By discharge from hospital, 4weeks and 12 weeks postoperatively.];To assess post-operative complications in relation to anaemia such as anaemia symptoms requirement for blood transfusion, infection.<br><br>This will be done through hospital notes and radiology and laboratory and diagnostics[by discharge until end of study at 3 months.];Lenghth of hospital stay (LOS) <br>[Number of days of hospital admission from the operative procedure date till patients discharge date.]