Effect of the number of epoetin alpha injections on the hemoglobin level of anaemic patients eligible for elective orthopedic surgery

Completed

• Conditions: anemia; 10038158; 10005944

• Registration Number: NL-OMON45498
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-09-30
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 45

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

* 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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the increase in Hb concentration after each epoetin<br /><br>alpha injection on day -1 versus day -7 before surgery. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary study parameters are the increase in Hb concentration after each<br /><br>epoetin alpha injection on day -14, day -7 and on the day of surgery (day 0).<br /><br>Baseline Hb concentration will be measured on day -21, at the start of the<br /><br>treatment with epoetin alpha.<br /><br><br /><br>Safety will be assessed by registration of adverse events, such as nausea and<br /><br>influence-like symptoms.<br /><br>Adherence to the prescribed treatment (epoetin alpha plus iron) will be<br /><br>assessed by the Medication Adherence Report Scale (MARS) questionnaire. </p><br>