None listed
Conditions
Brief summary
The Iron Heart Study will evaluate patient reported quality of life measures after administration of intravenous iron supplement in post-operative, anaemic, cardiac surgery patients. Post cardiac surgery patients (n = 80) who have a hemoglobin of less the 100mg/L on day 4 post-operative are eligible for this trial. Once consented, participants will be randomised to receive either an intravenous iron supplement infusion (ferric carboxymaltose 1000mg) or intravenous placebo (normal saline 0.9%) on Day 4 post cardiac surgery. Participants will be asked to complete an EQ-5D-5L Questionnaire on day 4 postoperatively prior to the infusion, and week 6 post-operatively. Participants will also be asked to have blood collected at weeks 2, 4 and 6 post-operatively. Blood results and questionnaire responses will be compared between the two groups to assess quality of life measures.
Interventions
Trial is evaluating if the administration of parenteral iron supplement in post-operative, anaemic, cardiac surgery patients result in improved self-reported quality of life measures. Participants will be randomised to receive either intravenous ferric carboxymaltose 1000mg or placebo. Participants randomised to the treatment arm will be administered intravenous ferric carboxymaltose 1000mg once on day 4 post-surgery prior to discharge. All participants will be administered a quality-of-life que
Trial is evaluating if the administration of parenteral iron supplement in post-operative, anaemic, cardiac surgery patients result in improved self-reported quality of life measures. Participants will be randomised to receive either intravenous ferric carboxymaltose 1000mg or placebo. Participants randomised to the treatment arm will be administered intravenous ferric carboxymaltose 1000mg once on day 4 post-surgery prior to discharge. All participants will be administered a quality-of-life questionnaire (EQ-5D-5L) on day 4 post-surgery prior to the infusion, and week 6 post-surgery. Strategies used to assess or monitor fidelity to the intervention include an audit of hospital notes and pharmacy accountability log by a trial coordinator not involved in the study.
Sponsors
St Vincent's Hospital Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Age 18+ years • Cardiac surgery patients with a post-operative day-4 haemoglobin of less than 100 g/L will be eligible for inclusion.
Exclusion criteria
• Have a history of haemochromatosis or polycythemia vera • Have a body weight of less than 50 kg • Patients with haemodialysis-dependent chronic kidney disease
Outcome results
None listed