Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients
ConditionIron Deficiency Anemia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age70+
Sponsordr. P. Noordzij
About this trial
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.
Eligibility criteria
Qualifiers
Mentally competent with age ≥ 70 years
Elective AVR or CABG surgery
No inotropic agents or ventilation at time of final inclusion (POD 1)
Expected discharge to general ward at POD 1
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Ferric Derisomaltose 100 MG/ML
- Sodium chloride
Treatment groups
310 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov