INTRAVENOUS IRON TO TREAT POSTOPERATIVE ANEMIA IN OLDER CARDIAC SURGERY PATIENTS: A RANDOMIZED CONTROLLED TRIA

Recruiting

• Conditions: low red blood cell count after surgery; postoperative low hemoglobin; 10007593

• Registration Number: NL-OMON56336
• Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 310

Inclusion Criteria

• Mentally competent with age >= 70 years
• Elective aortic valve replacement or coronary artery surgery
• Expected uncomplicated postoperative trajectory, defined as:
- No inotropic agents or ventilation at time of final inclusion (day 1)
- Expected discharge to general ward at day 1
• Moderate postoperative iron deficiency anemia, defined as:
- Hb between 85 and 110 g/L and
- Ferritin <100 µg/L or
- Iron saturation < 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified