Using intravenous iron to treat anemia after heart surgery in older patients
Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients: a Randomized Controlled Trial'
This study is testing if giving intravenous iron can help older patients recover from anemia after heart surgery and improve their overall well-being.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 310 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | St. Antonius Hospital Academic / other |
| Locations | 2 sites (Breda and 1 other locations) |
| Trial ID | NCT04913649 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of intravenous iron treatment for older patients experiencing postoperative anemia following elective cardiac surgeries, such as aortic valve repair and coronary artery bypass grafting. The study will involve 310 patients aged 70 and above, who will be randomly assigned to receive either intravenous iron or a placebo. The primary outcome will be assessed using the World Health Organization Disability Assessment score 90 days after surgery, alongside secondary measures related to dyspnea and health-related quality of life. The trial is designed as a double-blind, placebo-controlled study conducted at two centers.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 70 and older who are undergoing elective cardiac surgery and have moderate postoperative iron deficiency anemia.
Not a fit: Patients with a history of iron overload, severe renal failure, or recent intravenous iron treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery and quality of life for older cardiac surgery patients suffering from postoperative anemia.
How similar studies have performed: Other studies have shown promising results with intravenous iron treatment for anemia, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Breda and 1 other locations
- Amphia Hospital — Breda, Netherlands (Recruiting)
- St Antonius Hospital — Nieuwegein, Netherlands (Recruiting)
Study contacts
- Principal investigator: Peter Noordzij, MD, PhD — St. Antonius Hospital
- Study coordinator: Peter Noordzij, MD, PhD
- Email: p.noordzij@antoniusziekenhuis.nl
- Phone: 883203000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.