Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients

Launched by DR. P. NOORDZIJ · Jun 3, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of intravenous (IV) iron treatment on older patients who develop anemia after heart surgery. Anemia means having low levels of red blood cells, which can slow down recovery and affect overall health. The researchers want to see if giving IV iron helps these patients feel better and recover faster 90 days after their surgery. The study will involve 310 patients aged 70 and older who are having specific types of heart surgeries (like valve replacement or bypass surgery) and are expected to have smooth recoveries.

To participate in this trial, patients need to be mentally capable, have moderate anemia defined by certain blood test results, and meet specific health criteria. They will be randomly assigned to receive either the IV iron treatment or a placebo (a treatment that looks like the real one but has no active ingredients). This means that neither the patients nor the doctors will know who is getting which treatment. Participants will be closely monitored throughout the study, and their health will be evaluated at different stages to assess the benefits of the treatment. Overall, this trial aims to improve recovery experiences for older adults undergoing heart surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Mentally competent with age ≥ 70 years
• • Elective AVR or CABG surgery
• * Expected uncomplicated postoperative trajectory, defined as:
• • No inotropic agents or ventilation at time of final inclusion (POD 1)
• • Expected discharge to general ward at POD 1
• * Moderate postoperative IDA, defined as:
• • Hb between 85 and 110 g/L and
• • Ferritin \<100 µg/L or
• • Iron saturation (TSAT) \< 20%
• Exclusion Criteria:
• • Medical history of iron overload/haemochromatosis
• • Medical history of liver cirrhosis or ALT/AST value in blood serum triple of normal value (female patients: ALT \>120, AST \>105 U/L. Male patients: ALT\>150, AST\>135 U/L)
• • Severe renal failure (eGFR\<15ml/min/1.73m2)
• • Recent treatment with IVI (\<12 weeks prior)
• • Serious or severe allergic reaction to IVI in medical history
• • Severe asthma or eczema in medical history (atopic constitution)