anemia
Conditions
Interventions
Sponsors
Sint Maartenskliniek
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Indication for treatment with epoetin alpha according to current guidelines and the opinion of the anaesthesiologists. Epoetin alpha is prescribed to patients with a preoperative Hb level between 10.0 * 13.0 g/dL, scheduled for elective orthopedic surgery with an expected blood loss of 900-1800 mL.
Exclusion criteria
Exclusion criteria: * Any contra-indication for the use of epoetin alpha (hypersensitivity to epoetin alpha or any component of the formulation, uncontrolled hypertension, pure red cell aplasia due to epoetin alpha) * Myocardial infarction or cerebral vascular accident within 6 months before inclusion * Serious coronary disease * Sickle cell anemia * Pregnancy or lactation * Existing use of iron supplementation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the increase in Hb concentration after each epoetin alpha injection on day -1 versus day -7 before surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary study parameters are the increase in Hb concentration after each epoetin alpha injection on day -14, day -7 and on the day of surgery (day 0). Baseline Hb concentration will be measured on day -21, at the start of the treatment with epoetin alpha. Safety will be assessed by registration of adverse events, such as nausea and influence-like symptoms. Adherence to the prescribed treatment (epoetin alpha plus iron) will be assessed by the Medication Adherence Report Scale (MARS) questionnaire. | — |
Countries
The Netherlands
Outcome results
None listed