STRategies to Improve Donor ExperienceS (STRIDES)
Research type
Research Study
Full title
STRategies to Improve Donor ExperienceS (STRIDES): A cluster randomised trial to evaluate interventions to prevent vasovagal reactions among whole blood donors
IRAS ID
243737
Contact name
Emanuele Di Angelantonio
Contact email
Sponsor organisation
NHS Blood and Transplant
Duration of Study in the UK
10 years, 0 months, 1 days
Research summary
Feeling faint and fainting (i.e., vasovagal reactions [VVRs]) are the most common acute complications of blood donation. There is, however, limited reliable evidence about how to prevent VVRs. We will, therefore, conduct a powerful pragmatic trial embedded within NHS Blood and Transplant (NHSBT), drawing on input provided after extensive consultation with a variety of stakeholders, including blood donors, NHSBT staff and leadership, and a team of multi-disciplinary applied health researchers. The trial design has been tailored to the specific needs and circumstances of NHSBT, and to the particular interventions to be evaluated.
Following a 4-month feasibility phase, we will conduct a cluster-randomised cross-over/stepped-wedge factorial trial over 3 years involving the entire blood service. We will randomise ~72 blood donation teams across England (i.e., the study’s “clusters”) to combinations of the following four trial interventions compared with current NHSBT practice:
1) isotonic hydration before donation: 500ml isotonic drink vs 500ml plain water;
2) time on donation chair after donation: 3-minutes before standing vs 2-minutes;
3) modified applied muscle tension (AMT): new AMT vs current practice of AMT;
4) psychosocial intervention: preparatory materials vs nothing.After 36-months of monitoring, the primary endpoint will be the number of in-session VVRs with loss of consciousness. Secondary endpoints will include: all in-session VVRs; delayed VVRs; and any in-session non-VVR adverse events or reactions. As key concurrent goals are to advance understanding of the determinants of VVRs and to develop prevention strategies for VVRs tailored to specific donor sub-populations (e.g., based on demographic, biological, psychosocial, and other characteristics) and to conduct more detailed studies through re-contact of subsets of donors, we will create a BioResource that underpins these efforts.
The study will: yield evidence-based policies to reduce VVRs; lead to improvements in donor-health, experience, and service efficiency; reduce NHSBT’s medicolegal liabilities; and advance scientific understanding.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
18/EE/0284
Date of REC Opinion
21 Nov 2018
REC opinion
Further Information Favourable Opinion