Actively Recruiting
Led by dr. P. Noordzij · Updated on 2026-04-27
310
Participants Needed
2
Research Sites
4 weeks
Total Duration
D
dr. P. Noordzij
Lead Sponsor
P
Pharmacosmos A/S
Collaborating Sponsor
Researchers are studying the effect of intravenous iron treatment on postoperative iron deficiency anemia in older patients who have undergone elective cardiac surgery with cardiopulmonary bypass. The study aims to assess how this treatment impacts disability 90 days after surgery. This is a randomized, placebo-controlled, double-blind trial involving 310 elderly patients aged 70 years and older who have moderate postoperative iron deficiency anemia. Participants will receive either a single dose of intravenous ferric derisomaltose, dosed at 20mg per kilogram of body weight and infused over approximately 60 minutes, or a placebo consisting of sodium chloride 0.9% solution. Vital signs are monitored during the infusion and for 30 minutes afterward. The treatment is given on postoperative day 1 after uncomplicated elective aortic valve repair or coronary artery bypass graft surgery. During the study, participants will be evaluated for disability using the WHO Disability Assessment score 12-item version at 90 days after surgery. Additional assessments include patient-reported outcomes on breathing difficulty and quality of life, blood transfusion requirements, hemoglobin and reticulocyte hemoglobin content changes, hospital complications, and functional tests such as the 6-minute walk test. Safety and health status are monitored throughout the study period, which extends to 90 days post surgery.
CONDITIONS
Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Postoperative day 1
Participants undergo elective aortic valve repair or coronary artery bypass graft surgery and receive post-operative monitoring.
In-hospital monitoring during and immediately after surgery
Duration - Single treatment lasting approximately 60 minutes with monitoring during administration and for 30 minutes afterwards
Participants receive a single dose of intravenous iron or placebo administered postoperatively to treat iron deficiency anemia.
1 visit (in-person) for treatment administration
Duration - Up to 7 days after surgery
Participants are monitored for red blood cell transfusions, hemoglobin levels, reticulocyte hemoglobin content, complications, and recovery outcomes related to anemia and functional status.
Daily or as needed visits during hospital stay up to 7 days
Duration - 90 days after surgery
Participants are assessed for disability, patient-reported outcomes related to dyspnea and quality of life, and overall recovery status 90 days after surgery.
1 visit (in-person or remote) at 90 days post-surgery
Total: 2 locations
1
Amphia Hospital
Breda, Netherlands
Actively Recruiting
2
St Antonius Hospital
Nieuwegein, Netherlands
Actively Recruiting
P
Peter Noordzij, MD, PhD
R
Rosa Smoor, MD
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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R M Smoor, T C D Rettig, L M Vernooij...
https://pubmed.ncbi.nlm.nih.gov/37885026