NCT04913649 Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients
| NCT ID | NCT04913649 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | dr. P. Noordzij |
| Condition | Iron Deficiency Anemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 310 participants |
| Start Date | 2021-09-23 |
| Primary Completion | 2026-11 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
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)