A talk by Laura Green from TBS24

1. Whole Blood for
Trauma
Haemorrhage: UK
experience
Laura Green
Consultant Haematologist, NHS Blood & Transplant and
Bar ts Health Trust
Reader in Transfusion Medicine , Queen Mar y University of
London

2. Outline
§ Whole Blood Program
• Results of Red Cell and Plasma study
• Study of Whole blood in Frontline Trauma (SWiFT) trial

3. UK guidelines
§ British Society for Haematology
guideline (2015) & National Institute for
Health & Care Excellence (NG 39, 2016)
§ Use 1:1 ratio of Red Blood Cell (RBC) to
Fresh Frozen Plasma (FFP) for trauma
bleeding patients

4. Pre-hospital transfusion
§ February 2016 - concerns raised about
transfusing RBC + FFP pre-hospital
o Limited space
o Limited IV access
o Weight
o Time is of essence
§ Whole Blood preferred component

5. Current Alternative
Leucodepletion filter remove
platelets
Red cells & Plasma (RCP)
Leucodepletion filter that spare
platelets available
Whole Blood (WB)

6. Whole Blood Program
§ Assess the RCP component
§ Develop WB component (new LD filters)
§ Plan/design a future trial in pre-hospital setting (subject to WB development
work, the feasibility study)

7. RCP study
§ Primary objective
Percentage of days of ‘On Time in Full’ delivery
Wastage level in hospital (Royal London Hospital)
§ Secondary objectives
1. Evaluate clinical outcomes of RCP (24 hrs & 30 days mortality)
2. Assess practical advantages to transfusing RCP vs. separate
components/products
3. Evaluate safety of RCP (group O RhD Negative, Kell Negative
component)

8. RCP study (Oct 2018 – Oct 2020)
§ RBC was replaced with RCP (gr O, RhD neg, Kell neg) in London Air Ambulance
§ Population: all trauma patients requiring blood transfusion pre-hospital by
LAA will be transfused RCP
§ Comparators:
1. Retrospective: RBC in pre-hospital in London (March 2015 - Aug 2018)
2. Prospective: RBC + thawed FFP (or lyoplas) in pre-hospital outside London

9. Wastage level for RCP
0%
10%
20%
30%
40%
50%
60%
70%
80%
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Months
MucCullagh J et. al., BMJ Open Quality 2021;10:doi:10.1136/ bmjoq-2021-001396
Feasibility target
Go criteria to full
implementation
Criteria to reassess
and adjust protocol
Stop criteria
Component wastage ≤8% wastage 9% - 30% wastage >30% wastage
Trauma
patients in AE
Research
fellows Other
patients

10. Demographics
RBC RBC+P RCP
N=223 N=391 N=295
Median (Interquartile Range) unless otherwise stated
Age, mean (SD) 36.0 (19.3) 42.9 (19.8) 35.6 (19.2)
Male, n (%) 178 (80.5%) 287 (75.5%) 244 (83.8%)
Time from injury to scene arrival
(mins)
22.5 (14.3, 25.2) 31.4 (26.3, 36.8) 24.6 (14.8,26.1)
Time from injury to hospital arrival
(mins)
79.3 (64.2, 89.7) 97.4 (75.2, 107.4) 81.5 (67.4, 91.2)
Blunt Injury, n (%) 124 (55.6%) 304 (80.0%) 151 (51.9%)
Injury Severity Score 33.7 (24, 41) 31.6 (23, 44) 30.1 (22, 43)
AIS Head >3 27/100 (27%) 51/217 (24%) 38/180 21%
Pre-hospital physiology
SBP (mmHg) 82.0 (68.0;95.0) 78.0 (67.0;90.0) 79.0 (59.0;100)
HR (bpm) 121 (110;133) 110 (81.0;130) 109 (85.5;135)
HR 0 and SBP 0, n (%) 55 (25%) 81 (21%) 89 (31%)
SBP <90, n (%) 198 (88%) 341 (89%) 243 (84%)
Resuscitative and coagulopathy markers at hospital arrival
N=87/158 N=178/285 N=194/214
INR > 1.2, n (%) 29 (38%) 52 (30%) 39 (29%)
Base Excess (mmol/L) -8.00 (-12.88;-4.93) -5.60 (-9.90;-2.42) -7.80 (-14.12;-3.00)
pH 7.16 (7.01;7.27) 7.24 (7.12;7.32) 7.17 (7.01;7.29)
Lactate (mmol/L) 4.90 (2.80;8.70) 4.10 (2.40;7.00) 6.50 (3.30;11.2)
Tucker H et. al. Critical Care.
2023: 27 (1), 1-10

11. Adjusted mortality
Model 1 OR 95%CI P value
RBC 1
RBC+P 0.60 0.32 1.13 0.116
RCP 0.69 0.52 0.92 0.012
Model 2 Adjusted for prehospital variables + interaction between treatment and injury
Blunt
RBC 1
RBC+P 0.94 0.48 1.86 0.863
RCP 1.03 0.75 1.41 0.848
Penetrating
RBC 1
RBC+P 0.22 0.10 0.53 0.001
RCP 0.39 0.20 0.76 0.006
No difference in the 30-day mortality
Tucker H et. al. Critical Care. 2023: 27 (1), 1-10

12. Practical advantages
2x RCP
2x RBC &
2x TP
2x RBC &
2x Lyoplas
Non-
compressible
abdominal &
pelvic
haemorrhage
Pre-hospital
‘Code Red’
Outcomes
Scenario Pre-Hospital Team Intervention
Complete
transfusion
of all units
Team A
Team B
Team C
Flow Time
Nr of steps within the
flow time
Nr of people within the
flow time
Touch time
Nr of component
checks within the flow
time
Harriet Tucker (QMUL)

13. Results - logistical benefits for RCP
Arms
Flow time Touch Time
No. of
steps
No of
equip.
No of
checks
No of people
2 RBC + 2 FFP 12min 20sec 5min 21sec 40 10 16 2
2 RBC + 2
Lyoplas
18min 29sec 15min 3sec 46 12 16 3
2 RCP 6min 31sec 2min 31secs 28 4 8 2

14. WB filters - Platelet Count
Huish S. et. al. Transfusion. 2021;61:3224–3235

15. Future trial - 4 Systematic Reviews

16. A survey to define the
prehospital blood resuscitation
practices of UK Air Ambulances
Ed Barnard, Laura Green, Tom Woolley
Simon Stanworth, Rebecca Cardigan, Jason Smith
2019
n=12k
n=709
92 mins
n=18
Air Ambulances / n (%)
Blood component
combinations
7 (36.8%)
Red cells + FDP
6 (31.6%)
Red cells + plasma*
3 (15.8%)
Red cells only
1 (5.3%)
FDP only
1 (5.3%)
Red cells in plasma**
1 (5.3%)
No products
15 (79.0%) UK AAs interested to take part
in whole blood research
+24
gastro
vascular
40
non-trauma
patients
89%
8%
obstetric

17. RBC + Lyophilize
plasma
Sodium Chloride Adjusted risk ratio
(95% CI)
Adjusted average diff
(95%CI)
Primary outcome
Episode mortality or
failure to clear
lactate
128/199 (64%) 136/210 (65%) 1·01 (0·88 to 1·17);
p=0·86
–0·025% (–9 to 9);
p=1·00
Death
Within 3 h 32/197 (16%) 46/208 (22%) 0·75 (0·50 to 1·13);
p=0·17
–7% (–15 to 1)†; p=0·08
Within 30 days 86/204 (42%) 99/219 (45%) 0·94 (0·76 to 1·17);
p=0·59
–4% (–13 to 6); p=0·44
Lancet Haematol 2022; 9: e250–61

18. Red cells & Plasma
Whole Blood
Combined components pre-hospital
§ Higher wastage
§ Logistical benefits
§ RCP vs. standard of care no
difference
§ Evaluated new leukocyte-depleted
filters
§ Clinical outcomes for WB unknown
§ Clinicians wanted high quality
evidence on Whole Blood
Pre-trial

19. The SWIFT Trial
Studying Whole blood In Frontline Trauma
A randomised controlled trial of pre-hospital whole blood versus standard care for the resuscitation
of patients with life-threatening haemorrhage

20. Research Question
§ Is pre-hospital WB transfusion superior to standard care in reducing Mortality or Massive
Transfusion (≥10 units of any blood products) at 24 hrs?
SECONDARY QUESTIONS
§ Mortality and morbidity up to 30 days
§ Length of stay in intensive care and in hospital
§ Safety
§ Health-related quality-of-life at 3 months
§ Cost-effectiveness

21. Eligibility Criteria
INCLUSION CRITERIA
§ Patient (any age) requiring pre-hospital blood transfusion to treat traumatic life-
threatening bleeding.
§ Attended by a participating Air Ambulance team.
EXCLUSION CRITERIA
§ No intravenous or intraosseous access.
§ Knowledge that patient will object to being given blood transfusion for any reasons.

22. Proposed Trial Design
§ Patients will be randomised in 1:1 to:
Ø Two units of whole blood
Ø Two units of RBC and two units of (any form of) plasma
§ All patients will receive standard care according to the major
haemorrhage protocol in the receiving hospital
§ Randomisation will be performed by the Transfusion Laboratories
§ Patients in traumatic cardiac arrest at the time of arrival on-scene,
and non-traumatic bleeding, will be excluded
§ Number of patients required: 848 patients

23. Air Ambulance Kent Surrey Sussex
Dorset and Somerset Air Ambulance
Essex and Herts Air Ambulance
Hampshire and Isle of Wight Air Ambulance
Great North Air Ambulance
Great Western Air Ambulance
London’s Air Ambulance
Magpas Air Ambulance
North West Air Ambulance
Thames Valley Air Ambulance
• Canada
• New Zealand
Air Ambulances in England International sites
Funding – UK site
§ NHSBT and 10 charities
contributing equally
MOD
NHSBT
AA Charities

24. Site update
Site type Open In set-up
Air Ambulances 9 1
Transfusion labs 9 1
Receiving hospitals (planned) 24 1
Total number of sites 45
Site staff involved ~236

25. 434 patients recruited (23 Jan 2024)

26. Acknowledgments
Rebecca Cardigan
Sarah Morley
Gail Miflin
Jane Davies
Dave Edmondson
Sian Huish
Steven Tassen
Peter Basham
Michael Wiltshire
Simon Stanworth
Heidy Doughty
Alastair Hunter
Ross Davenport
Karim Brohi
Harriet Tucker
Anne Weaver
Josephine McCullagh
Julia Lancut
NHS Blood &
Transplant
Queen Mary
University of London
Barts Health
Trust

27. SWiFT Trial Team
Laura Green
Chief Investigator
Jason Smith
Chief Investigator
Anne Weaver Richard Lyon Ed Barnard Gavin Perkins Simon
Stanworth
Rebecca
Cardigan
Tom Woolley Helen
Thomas
Annie
Hawton
Claire Rourke Jo Lucas Viona Rundell Emily Sanderson Laura Smith Nikki Dallas
Laura Silsby Jane Davies Peter
Basham

28. Thank you!