Using intravenous iron to treat anemia after heart surgery in older patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.