COMPARE: a study of haemoglobin testing methods
Research type
Research Study
Full title
Comparison of NHSBT’s current approach with three alternative strategies to assess haemoglobin levels in whole blood donors (COMPARE Study)
IRAS ID
187098
Contact name
Emanuele Di Angelantonio
Contact email
Sponsor organisation
NHS Blood and Transplant
Duration of Study in the UK
10 years, 0 months, 0 days
Research summary
To protect the health of donors (eg, to prevent anaemia) and ensure the quality of blood products, blood services are mandated to measure haemoglobin levels in advance of each blood donation.
NHS Blood and Transplant (NHSBT) screens haemoglobin levels of donors using a crude but cheap method. A drop of a donor’s blood is put into a copper sulphate solution. If the drop sinks sufficiently, then it is judged that the donor’s haemoglobin levels are high enough to donate. If the drop doesn’t sink sufficiently, then it triggers use of a more precise and costly test (“Hemocue®” from a venous sample). No other blood service of a major industrialised country uses this approach any longer.
Our previous work indicates that NHSBT’s current method results in about 10% of donors being inappropriately bled (ie, donations from people who have haemoglobin levels below the EU’s mandated safety cut-off points). Alternative methods used by other blood services may be more accurate, user-friendly, and time-efficient. However, their comparative merits have not been robustly evaluated.
In a study of 31,000 donors in England attending for routine donations, we will compare three alternative methods for haemoglobin testing (ie, a “post-donation” method, capillary blood Hemocue®, and non-invasive spectrometry), comparing each with NHSBT’s current approach and with a “gold standard” haematology analyser. The study’s principal outcome will be the proportion of donors that would have been inappropriately bled with each method.
Secondary key outcomes will include feasibility and acceptability of the methods for donors and NHSBT staff, cost-effectiveness, and test performance in donor subpopulations (eg, by age, sex, ethnicity, genetic make-up).
Results from this study should help to shape NHSBT (and international) policy concerning haemoglobin screening and to inform a major imminent procurement decision of NHSBT.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
15/EE/0335
Date of REC Opinion
18 Dec 2015
REC opinion
Further Information Favourable Opinion