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Heath technology assessment on use of epoetinum alfa for pre-orthopaedic surgery

Introduction

About 15% of all transfusions of red blood cells are performed during orthopaedic surgery such as a hip replacement. The cost of providing such blood has increased following the adoption of precautionary measures to minimise the risks associated with transfusion. However risks remain and these are a concern for all patients who are transfused in Scotland (SIGN Guideline No 54. Perioperative blood transfusion, October 2001).
Guidelines are available to help clinicians decide when transfusion of blood from a donor (known as allogenic blood transfusion) is appropriate and to help minimise the avoidable risks of transfusion.
 
NHS Quality Improvement Scotland (NHS QIS) is undertaking a health technology assessment (HTA) to critically appraise the existing literature on the clinical and cost effectiveness of one possible strategy to reduce the need for transfusion. This blood sparing strategy involves injecting a hormone called epoetinum alfa into patients with non-iron-deficient anaemia, prior to major orthopaedic surgery.
 
The purpose of this document is to summarise the HTA.
 
This document describes the:
  • scope of the HTA
  • clinical and cost-effectiveness questions
  • issues affecting patient care
  • indicative timelines for the project
  • background information on the HTA process and methodology.
The scope of the assessment has been informed by a consultation that closed on 21st June 2005.

Scope of the HTA

The scope of the HTA is limited to the following aspect of the licensed indication for epoetinum alfa:

Epoetinum alfa can be used to increase the yield of autologous blood from patients in a predonation programme. Its use in this indication must be balanced against the reported risk of thrombo-embolic events. Treatment should only be given to patients with moderate anaemia (Hb 10-13 g/dl [6.2-8.1 mmol/l], no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males.
Epoetinum alfa can be used to reduce exposure to allogeneic blood transfusions in adult non-iron-deficient patients prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications. Use should be restricted to patients with moderate anaemia (eg Hb 10-13 g/dl) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1800 ml) (Summary of Product Characteristics Eprex ).

Literature searches indicated that there are small trials using epoetinum alfa in other surgery, particularly in cardiac surgery. However, the safety of such use has not been demonstrated by the manufacturer so these potential applications will not be considered further.

Expected Date of Publication

Consultation report: April 2006
Final report: September 2006

Additional information