anemia
Conditions
Interventions
Single dose intravenous iron (Ferric carboxymaltose). This is done with a short
treatment of 1000mg for at least 15 minutes during the preoperative visit> 2
weekly and desirable OK 4 weeks to a maxi
Sponsors
Isala Zwolle
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age 18+ Patient has been discussed within the heart team and undergoes elective cardiac surgery There is an iron deficiency with ferritin
Exclusion criteria
Exclusion criteria: Known disorders of haematopoiesis (eg myelodysplastic syndrome, polycythaemia vera) • Known disorders of iron metabolism (iron overload disease) • Clinical patient with planned duration between heart team and OK 5 kg 3 months prior to heart team meeting. • Known allergy parenteral iron preparations • The use of Ferinject is contraindicated in cases of o Hypersensitivity to the active substance or ferric carboxymaltose for (one of) the adjuvant (s), sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), water for injection o severe hypersensitivity reactions to other parenteral iron products. o Not to iron deficiency anemia attributed, eg. other microcytic anemia o Evidence of iron overload or disturbances in utilization of iron
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the total number of deployed units of blood transfusion (transfusion number of RBCs) per group (PRICAR PRICAR-1 and-2) and the number of patients without the administration of blood transfusion units (RBCs) for inclusion in the ISALA. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include infection during and after hospitalization, length of hospital stay and hospital admissions, the amount and type of care following surgery, including unplanned readmissions during the 12-month follow-up, physical health and their costs. The quality of life according to SF-36 pre- and post through a survey was conducted, will also be analyzed. | — |
Countries
Netherlands
Outcome results
None listed