RecruitingPhase 4

Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients

Netherlands310 participantsStarted 2021-09-23

Plain-language summary

Postoperative anemia is common in cardiac surgery with cardiopulmonary bypass. Iron deficiency delays the recovery from postoperative anemia and may negatively affect the postoperative trajectory of cardiac surgery patients. The objective of the study is to determine the effect of treatment of postoperative iron deficiency anemia with intravenous iron on disability 90 days after surgery. This will be evaluated in a randomized placebo-controlled double blind two-center trial in which 310 elective cardiac surgery patients will be included.

Who can participate

Age range

70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Disability

Timeframe: 90 days after elective cardiac surgery

Trial details

NCT IDNCT04913649

Sponsordr. P. Noordzij

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11

Contact for this trial

Peter Noordzij, MD, PhD

883203000 p.noordzij@antoniusziekenhuis.nl

View on ClinicalTrials.gov More Iron Deficiency Anemia trials