Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Iron Deficiency Anemia
In brief
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.
Key facts
- Study ID
- NCT04913649
- Run by
- dr. P. Noordzij
- People needed
- 310
- Starts
- 2021-09-23
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-04-27
Who can join
Age: 70 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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%
You may not qualify if…
- 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 is running
- Amphia Hospital — Breda, Netherlands (enrolling)
- St Antonius Hospital — Nieuwegein, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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