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RecruitingPhase 4NCT04913649

Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients

Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients: a Randomized Controlled Trial'

Sponsor

dr. P. Noordzij

Enrollment

310 participants

Start Date

Sep 23, 2021

Study Type

INTERVENTIONAL

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

Min Age: 70 Years

Inclusion Criteria9

  • 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 Criteria6

  • 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)

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Interventions

DRUGFerric Derisomaltose 100 MG/ML

Postoperative treatment with a single dose IVI (ferric derisomaltose), with a dose of 20mg/kg in approximately 60 minutes.

DRUGSodium chloride

Postoperative treatment with a single dose NaCl 0.9% in approximately 60 minutes.

Locations(2)

Amphia Hospital

Breda, Netherlands

St Antonius Hospital

Nieuwegein, Netherlands

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NCT04913649