Anaemia following cardiac surgery MedDRA version: 22.0 Level: LLT Classification code 10057220 Term: Acute post haemorrhagic anaemia System Organ Class: 100000004851 MedDRA version: 20.0 Level: LLT Classification code 10022974 Term: Iron deficiency anemia System Organ Class: 100000004851
Conditions
Interventions
Trade Name: MonoFer
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ferric derisomaltose
CAS Number: 9004-66-04
Other descriptive name: IRON(III) ISOMALTOSIDE 1000
Concentration unit:
Sponsors
Aarhus University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients undergoing first-time, non-emergent cardiac surgery 2. Moderate anemia on the first postoperative day (i.e. a haemoglobin concentration of = 5.0 mmol/l [8 g/dl] and =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: Absolute and relative contraindications to treatment with intravenous iron Treatment with intravenous iron within 4 weeks prior to surgery. Untreated vitamin B12 or folate deficiency. Anticipated inability to perform a six-minute walk test. Women of childbearing potential, pregnant and nursing women. Anticipated postoperative length of stay in the intensive care unit (ICU) > 48 hours. Patients incapable of giving consent personally. Significantly increased risk of non-adherence or loss to follow-up. Active participation in another interventional trial with potential impact on postoperative anaemia or exercise capacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of single-, high-dose intravenous iron infusion versus oral iron supplementation for the treatment of anaemia following cardiac surgery.;Secondary Objective: To compare single-, high-dose intravenous iron infusion versus oral iron supplementation in the following postoperative outcomes: -Iron deficiency -Red blood cell transfusion requirements -Exercise capacity -Health-related quality of life -Fatigue -Treatment side-effects To perform a cost-effectiveness analysis of intravenous iron supplementation ;Primary end point(s): The proportion of participants who are - neither anemic at 4-week follow-up - nor have received red blood cell transfusion since randomisation. According to WHO criteria, anaemia is defined as a haemoglobin concentration of less than 8.1 mmol/l (13 g/dl) in men and less than 7.4 mmol/l (12 g/dl) in women ;Timepoint(s) of evaluation of this end point: 4 weeks after randomisation (approximately 4 weeks postoperatively) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Mean change in haemoglobin level from baseline 2. Proportion of participants with a haemoglobin increase = 1.3 mmol/l (= 2 g/dL) from baseline 3. Mean haemoglobin level, reticulocyte count, plasma iron, ferritin, transferrin saturation 4. Mean change in haemoglobin level, reticulocyte count, plasma iron, ferritin, transferrin saturation from before surgery 5. Proportion of participants transfused with allogeneic red blood cells after randomisation 6. Six-minute walk distance 7. Health-related quality of life, assessed with the standardized EuroQol Group five dimensions questionnaire (EQ-5D). 8. Fatigue, assessed with the Multidimensional Fatigue Inventory (MFI-20). 9. New York Heart Association (NYHA) functional class. 10. Quality of recovery, assessed with the Quality of Recovery score (QoR-9). 11. Gastrointestinal symptoms. 12. Treatment adherence to oral study drug 13. Cost-effectiveness analysis;Timepoint(s) of evaluation of this end point: 4 weeks after randomisation (approximately 4 weeks postoperatively) | — |
Countries
Denmark
Contacts
Public ContactDepartment of Anesthesia, B&O Øst 1
Aarhus University Hospital
Outcome results
None listed