Actively Recruiting
Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients
Led by dr. P. Noordzij · Updated on 2026-04-27
310
Participants Needed
2
Research Sites
270 weeks
Total Duration
On this page
Sponsors
D
dr. P. Noordzij
Lead Sponsor
P
Pharmacosmos A/S
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mentally competent with age 7 70 years
- Undergoing elective aortic valve repair (AVR) or coronary artery bypass graft (CABG) surgery
- Expected uncomplicated postoperative course with no inotropic agents or ventilation on postoperative day 1
- Expected discharge to general ward on postoperative day 1
- Moderate postoperative iron deficiency anemia with hemoglobin between 85 and 110 g/L
- Ferritin less than 100 �b5g/L or iron saturation less than 20% on postoperative day 1
You will not qualify if you...
- History of iron overload or hemochromatosis
- History of liver cirrhosis or elevated liver enzymes more than three times normal (ALT >120 U/L or AST >105 U/L for females; ALT >150 U/L or AST >135 U/L for males)
- Severe kidney failure with estimated glomerular filtration rate below 15 ml/min/1.73m2
- Treatment with intravenous iron within the past 12 weeks
- History of serious or severe allergic reactions to intravenous iron
- History of severe asthma or eczema (atopic constitution)
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Amphia Hospital
Breda, Netherlands
Actively Recruiting
2
St Antonius Hospital
Nieuwegein, Netherlands
Actively Recruiting
Research Team
P
Peter Noordzij, MD, PhD
CONTACT
R
Rosa Smoor, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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