Evaluation of interventions to prevent vasovagal reactions among whole blood donors: rationale and design of a large cluster randomised trial

British Heart Foundation Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK. am2663@medschl.cam.ac.uk. Victor Phillip Dahdaleh Heart and Lung Research Institute, University of Cambridge, Cambridge, UK. am2663@medschl.cam.ac.uk. National Institute for Health and Care Research Blood and Transplant Research Unit in Donor Health and Behaviour, University of Cambridge, Cambridge, UK. am2663@medschl.cam.ac.uk. British Heart Foundation Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK. Victor Phillip Dahdaleh Heart and Lung Research Institute, University of Cambridge, Cambridge, UK. National Institute for Health and Care Research Blood and Transplant Research Unit in Donor Health and Behaviour, University of Cambridge, Cambridge, UK. Health Data Research UK Cambridge, Wellcome Genome Campus and University of Cambridge, Cambridge, UK. NHS Blood & Transplant, Blood Donation, Barnsley, UK. School of Psychological Sciences, Macquarie University, Sydney, NSW, Australia. Centre for Emotional Health, Macquarie University, Sydney, NSW, Australia. Department of Haematology, University of Cambridge, Cambridge Biomedical Campus, Cambridge, UK. National Institute for Health and Care Research BioResource, Cambridge University Hospitals NHS Foundation, Cambridge Biomedical Campus, Cambridge, UK. NHS Blood and Transplant, Bristol, UK. University of Leicester, Leicester, UK. British Heart Foundation Centre of Research Excellence, University of Cambridge, Cambridge, UK. Cambridge Centre of Artificial Intelligence in Medicine, University of Cambridge, Cambridge, UK. NHS Blood & Transplant, John Radcliffe Hospital, Oxford, UK. NHS Blood & Transplant, Ashford, UK. Data, Analytics and Surveillance, UK Health Security Agency, Nobel House, London, UK. MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK. Radcliffe Dept of Medicine and BRC Haematology Theme, University of Oxford, Oxford, UK. Department of Human Genetics, Wellcome Sanger Institute, Hinxton, UK. Health Data Science Centre, Human Technopole, Milan, 20157, Italy. NHS Blood and Transplant, Cambridge, UK.

Trials. 2023;24(1):512
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PICO Summary

Population

Whole blood donors enrolled in the Strategies to Improve Donor Experiences (STRIDES) trial from all 73 blood donation sites of National Health Service Blood and Transplant (NHSBT) in England (n= 1.4 million).

Intervention

(i) 500ml isotonic drink before donation; (ii) 3-min rest on donation chair after donation; (iii) New modified applied muscle tension (AMT); (iv) Psychosocial intervention using preparatory materials upon arrival and registration.

Comparison

NHSBT’s current practices: (i) 500ml plain water before donation. (ii) 2-min rest on donation chair after donation; (iii) Current practice of AMT; (iv) No psychosocial intervention.

Outcome

The primary outcome is the number of in-session vasovagal reactions (VVRs) with loss of consciousness. Secondary outcomes include all in-session VVRs, all delayed VVRs and any in-session non-VVR adverse events or reactions. Each site ("cluster") has been randomly allocated to receive one or more interventions during a 36-month period, using principles of cross-over, stepped-wedge and factorial trial design to assign the sequence of interventions. Researchers will test the hypothesis that that the implementation of one or more interventions, singly or in combination, will reduce VVRs when compared to current practice in NHSBT.
Abstract
BACKGROUND Vasovagal reactions (VVRs) are the most common acute complications of blood donation. Responsible for substantial morbidity, they also reduce the likelihood of repeated donations and are disruptive and costly for blood services. Although blood establishments worldwide have adopted different strategies to prevent VVRs (including water loading and applied muscle tension [AMT]), robust evidence is limited. The Strategies to Improve Donor Experiences (STRIDES) trial aims to reliably assess the impact of four different interventions to prevent VVRs among blood donors. METHODS STRIDES is a cluster-randomised cross-over/stepped-wedge factorial trial of four interventions to reduce VVRs involving about 1.4 million whole blood donors enrolled from all 73 blood donation sites (mobile teams and donor centres) of National Health Service Blood and Transplant (NHSBT) in England. Each site ("cluster") has been randomly allocated to receive one or more interventions during a 36-month period, using principles of cross-over, stepped-wedge and factorial trial design to assign the sequence of interventions. Each of the four interventions is compared to NHSBT's current practices: (i) 500-ml isotonic drink before donation (vs current 500-ml plain water); (ii) 3-min rest on donation chair after donation (vs current 2 min); (iii) new modified AMT (vs current practice of AMT); and (iv) psychosocial intervention using preparatory materials (vs current practice of nothing). The primary outcome is the number of in-session VVRs with loss of consciousness (i.e. episodes involving loss of consciousness of any duration, with or without additional complications). Secondary outcomes include all in-session VVRs (i.e. with and without loss of consciousness), all delayed VVRs (i.e. those occurring after leaving the venue) and any in-session non-VVR adverse events or reactions. DISCUSSION The STRIDES trial should yield novel information about interventions, singly and in combination, for the prevention of VVRs, with the aim of generating policy-shaping evidence to help inform blood services to improve donor health, donor experience, and service efficiency. TRIAL REGISTRATION ISRCTN 10412338. Registration date: October 24, 2019.
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine