Comparison of alternative strategies to assess haemoglobin levels in whole blood donors (COMPARE study)

Not Applicable

• Conditions: Measurement of haemoglobin concentration of potential whole blood donors.; Not Applicable

• Registration Number: ISRCTN90871183
• Lead Sponsor: HS Blood and Transplant

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33341984/ (added 27/04/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-13
• Last Update Posted: 13 November 2023
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 29029

Inclusion Criteria

1. Age =18 years and fulfilling all normal criteria for blood donation with the exception of pre-donation haemoglobin levels measured using the current NHSBT methods
2. Willing to undergo additional haemoglobin measurement
3. Willing to donate an extra blood sample for measurement of haemoglobin using an automated cell counter
4. Willing to come back for a subsequent appointment at standard donation interval (ie 12-wk and 16-wk for men and women respectively)

Exclusion Criteria

1. Participants who do not have internet access and/or are not willing to provide an email address for study correspondence (as the study will aim to be almost paper-less” and will involve remote web-based data collection)
2. Donors already enrolled in the INTERVAL randomised trial will be excluded

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint will be the numbers of donors in the study who would have been inappropriately bled by each method (ie, donors who had haemoglobin levels <125g/L for women and <135g/L for men, according to European Union regulations). The principal assessment will compare the current NHSBT screening method with each of the three other alternative methods listed above. Specific measures to be calculated include false pass rate, sensitivity and specificity in detecting haemoglobin levels below the recommended cut-offs for whole blood donation.

Secondary Outcome Measures

Name	Time	Method
We will study the following important and pre-specified secondary endpoints:<br> <br>1. Differences in the numbers of donors who would have inappropriately bled when comparing the various newer methods to be studied with one another<br>2. Differences in the numbers of donors who would have been inappropriately bled when comparing the two non-invasive devices to be studied with each other<br>3. Feasibility and acceptability of different methods, according to the views of and blood services staff<br>4. Cost-effectiveness of different methods<br>5. Variability of the performance of different methods by donors’ personal characteristics<br>6. Medium and long-term health consequences of inappropriately bleeding at donation.<br>7. Biological mechanisms underlying personal characteristics (such as genetic profile) that may influence recovery of haemoglobin levels and iron metabolism after blood donation