Status:
RECRUITING
Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients
Lead Sponsor:
dr. P. Noordzij
Collaborating Sponsors:
Pharmacosmos A/S
Conditions:
Iron Deficiency Anemia
Eligibility:
All Genders
70+ years
Phase:
PHASE4
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 c...
Detailed Description
Rationale: Postoperative anemia is common in cardiac surgery with cardiopulmonary bypass. Iron deficiency delays the recovery from postoperative anemia and may negatively affect the postoperative traj...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT04913649
Start Date
September 23 2021
End Date
December 1 2025
Last Update
December 2 2024
Active Locations (2)
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1
Amphia Hospital
Breda, Netherlands
2
St Antonius Hospital
Nieuwegein, Netherlands