Study of whole blood in frontline trauma
| ISRCTN | ISRCTN23657907 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23657907 |
| EudraCT/CTIS number | 2021-006876-18 |
| IRAS number | 300414 |
| Secondary identifying numbers | CPMS 52435, IRAS 300414 |
- Submission date
- 18/11/2022
- Registration date
- 07/12/2022
- Last edited
- 17/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English Summary
Background and study aims
Every year, uncontrolled bleeding due to major injury (major traumatic haemorrhage) accounts for more than 2 million deaths worldwide and 4,500 deaths in England. Blood transfusion is an essential part of the treatment for severe bleeding, and any delay in starting transfusion can reduce the chances of survival. In the UK patients are often transfused blood at the scene of an incident before they arrive at hospital. Transfusion may involve different blood components, red blood cells (important for carrying oxygen around the body), plasma (contains essential proteins to help blood clot) and platelets (small cells that are essential for blood clot formation). Most UK air ambulances treat bleeding patients with a combination of red blood cells and plasma, which come in separate bags. However, carrying separate blood component bags introduces logistical challenges due to the additional weight the team needs to carry; increased complexity as several bags may need to be given to each patient; and a potential delay in transferring patients to hospital. Whole blood contains red cells, plasma and platelets all in one bag, as taken from a blood donor. Giving a blood transfusion of all of the components in a single bag could overcome these challenges. The aim of this study is to assess the clinical and cost-effectiveness of pre-hospital whole blood administration versus standard care for traumatic haemorrhage.
Who can participate?
Patients of any age who have suffered a traumatic injury, attended by a participating Air Ambulance Service clinical team, who require pre-hospital blood transfusion to treat major traumatic haemorrhage.
What does the study involve?
In this study, one group of patients will be given transfusions of red blood cells and plasma. The other group of patients will receive transfusions of whole blood. The effects of the two different treatments will be compared by looking at survival in the two groups and the amount of blood needed over the first 24 hours after injury. At the end of the study the researchers will determine which of the transfusion types is better (or whether there is no difference between them), and the cost-effectiveness and safety of giving whole blood transfusions compared to red blood cells.
What are the possible benefits and risks of participating?
There are no known risks or benefits linked to/attributed to taking part in this study, and there are no known additional risks in participating in the study compared to the risk associated with transfusing blood components. Information collected as part of this trial may benefit patients in the future.
Where is the study run from?
NHS Blood and Transplant Clinical Trials Unit (UK)
When is the study starting and how long is it expected to run for?
March 2020 to June 2025
Who is funding the study?
The study has been funded by NHS Blood and Transplant, the Ministry of Defence and the following Air Ambulance Services:
1. Air Ambulance Kent Surrey Sussex (AAKSS)
2. Dorset and Somerset Air Ambulance (DSAA)
3. Essex and Herts Air Ambulance (EHAAT)
4. Hampshire and Isle of Wight Air Ambulance (HIOWAA)
5. Great North Air Ambulance (GNAAS)
6. Great Western Air Ambulance (GWAAC)
7. London’s Air Ambulance (LAA)
8. Magpas Air Ambulance (Magpas)
9. North West Air Ambulance (NWAA)
10. Thames Valley Air Ambulance (TVAA)
Who is the main contact?
NHS Blood and Transplant Clinical Trials Unit, swift@nhsbt.nhs.uk
Contact information
Public
Clinical Trial Coordinator
NHS Blood and Transplant Clinical Trials Unit
Long Road
Cambridge
CB2 0PT
United Kingdom
| Phone | +44 (0)1223 588091 |
|---|---|
| Viona.Rundell@nhsbt.nhs.uk |
Public
Trial Manager, Long Road
Cambridge
CB2 0PT
United Kingdom
| Phone | +44 (0)1223 588175 |
|---|---|
| swift@nhsbt.nhs.uk |
Study information
| Study design | Randomized treatment process-of-care management-of-care health-economic study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A multi-centre randomised controlled trial of the clinical and cost-effectiveness of pre-hospital whole blood administration versus standard care for traumatic haemorrhage |
| Study acronym | SWiFT |
| Study hypothesis | Pre-hospital leukocyte-depleted whole blood transfusion is better than standard care (component transfusion) in reducing the proportion of participants who experience death or massive transfusion at 24 hours. |
| Ethics approval(s) | Approved 12/09/2022, South Central - Oxford C Research Ethics Committee (Health Research Authority (Bristol), Ground Floor, Temple Quay House, 2 The Square, BS1 6PN, UK; +44 (0)207 104 8241, oxfordc.rec@hra.nhs.uk), ref: 22/SC/0072 |
| Condition | Traumatic haemorrhage |
| Intervention | Study design A randomised controlled trial of pre-hospital whole blood versus red blood cells and plasma (non-blinded), for the treatment of major traumatic haemorrhage. Type of participant to be studied Patients (of any age) who require a blood transfusion in the pre-hospital setting, for the treatment of major traumatic haemorrhage. Setting Pre-Hospital Emergency Medicine. Randomisation Randomised boxes containing the trial intervention (either two units of whole blood or two units of red blood cells and two units of plasma) will be prepared in advance by the Transfusion Laboratory Teams. The boxes will be supplied to the participating Air Ambulance Services. If they attend to a patient who has suffered major trauma and requires blood transfusion, the team will open the trial intervention box and administer the contents to the patient, in accordance with standard local blood transfusion protocols. The time that the box was opened will be recorded and referred to as the randomisation time for the purposes of follow-up data collection. Informed consent will not be obtained prior to the initiation of treatment, due to the life-threatening nature of the patient’s condition. Patients will be enrolled under an emergency waiver of consent, and informed consent will be sought (either directly from the participant, if they have capacity, or via a representative) as soon as practically possible. Treatment The intervention arm will be up to two units of whole blood (www.transfusionguidelines.org/red-book/annex-3/a3-6-whole-blood-leucocyte-depleted-for-clinical-studies). The control arm will be up to two units of red blood cells and up to 2 units of plasma (this is the current standard of care for the participating Air Ambulance Services). The plasma used in the control arm will either be fresh-frozen plasma (FFP) or LyoPlas (freeze-dried plasma). LyoPlas is classified as an IMP as it involves a manufacturing process. All other products used in this trial are blood components and fall under The Blood Safety and Quality Regulations. If bleeding continues after the trial intervention(s) have been administered, participants will receive further treatment as per standard of care. Follow-up of participants Patients will be reviewed as per standard clinical care. Data will be collected for the trial, for the secondary outcome measures, up to 90 days post-randomisation. Safety reporting Serious adverse events will be documented and reported up to 14 days post-treatment. The protocol lists events which are excluded from reporting (i.e. those which are recognised complications and consequences of major trauma). Qualitative research Alongside the randomised controlled trial, an 'implementation study' will be conducted. This will assess the acceptability and implementation of the intervention (whole blood). In this sub-study, qualitative methods will be used, involving interviews and focus groups with operational staff, patient representatives and blood donors. |
| Intervention type | Other |
| Primary outcome measure | The proportion of participants with traumatic haemorrhage who have died (all-cause mortality) or received a total of 10 or more units of any blood components in the first 24 hours from randomisation |
| Secondary outcome measures | Clinical Outcomes: 1. Individual components of the primary outcome: Proportion of participants who: 1.1. Experienced all-cause mortality at 24 hours from randomisation 1.2. Received a total of 10 or more units of any blood components in the first 24 hours of randomisation IV 2. All-cause mortality within 6 hours and separately 30 and 90 days of randomisation IV 3. Number of organ failure free days up to 30 days after randomisation, defined as the number of days free of advanced cardiovascular, advanced respiratory and advanced renal support. Each component of organ failure-free days will also be reported separately: 3.1. Number of days free of advanced respiratory support 3.2. Number of days free of advanced cardiovascular support 3.3. Number of days free of advanced renal support 4. Days in critical care and separately in an acute care hospital (up to 90 days) 5. Units of each blood component received in the 24 hours after randomisation IV (including prehospital transfusions): whole blood (WB) and red blood cells (RBC), plasma, platelets and cryoprecipitate 6. Amount of cell salvage received at 24 hours (in ml) after randomisation IV 7. Number of participants receiving additional haemostatic agents received at 24 hours after randomisation IV: recombinant Factor VIIa, fibrinogen concentrate, prothrombin complex concentrate (PCC), tranexamic acid (TXA) 8. Presence of coagulopathy (defined as prothrombin time above the limits of a normal range) in the first sample taken on arrival at an acute care hospital 9. Acid-base disturbance measured by lactate, base excess and pH level in the first sample taken on arrival at an acute care hospital Cost-Effectiveness Analysis Outcomes: 1. Incremental cost of the whole blood intervention 2. Hospital resource use to discharge or death 3. Health, social and wider care resource use to 90 days after randomisation 4. Health-related quality of life measured by EQ-5D-5L at 90 days after randomisation Safety Outcomes: 1. Thrombosis (arterial and venous thrombosis) up to 30 days after randomisation 2. All transfusion reactions/events relating to pre-hospital blood components which have been reported to SHOT (Serious Hazards of Transfusion) occurring in the first 14 days after randomisation |
| Overall study start date | 01/03/2020 |
| Overall study end date | 01/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | Planned Sample Size: 848; UK Sample Size: 848 |
| Participant inclusion criteria | 1. Patient (of any age) who has suffered a traumatic injury 2. Attended by a participating Air Ambulance Service (AAS) clinical team 3. Requires pre-hospital blood transfusion to treat major traumatic haemorrhage |
| Participant exclusion criteria | 1. No intravenous or intraosseous access 2. Knowledge that the patient will object to being given blood transfusion for any reasons 3. Blood already administered on-scene, prior to the arrival of the participating Air Ambulance team |
| Recruitment start date | 15/12/2022 |
| Recruitment end date | 12/09/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Liverpool
L9 7AL
United Kingdom
Maidstone Road
Chatham
Kent
ME5 9SD
United Kingdom
West Derby
Liverpool
L12 2AP
United Kingdom
Bristol
BS2 8BJ
United Kingdom
Bristol
BS2 8HW
United Kingdom
Henstridge
Templecombe
BA8 0TN
United Kingdom
Princes Street
Dorchester
DT1 1TS
United Kingdom
Redhill
RH1 5RH
United Kingdom
Earls Colne Business Park
Colchester
CO6 2NS
United Kingdom
Urlay Nook Road
Eaglescliffe
Stockton-on-tees
TS16 0QB
United Kingdom
Ashton Road
Bristol
BS3 2JH
United Kingdom
Thruxton Airfield
Thruxton
Andover
SP11 8PW
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
De Crespigny Park
Denmark Hill
London
SE5 8AB
United Kingdom
77 Mansell Street
London
E1 8AN
United Kingdom
St. Marys Street
Huntingdon
PE29 3PE
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
Woodward Road
Knowsley
L33 7UY
United Kingdom
Harlow
CM20 1QX
United Kingdom
London
E1 1BB
United Kingdom
Fulwood
Preston
PR2 9HT
United Kingdom
Newcastle upon Tyne
NE1 4LP
United Kingdom
Eccles
Salford
M6 8HD
United Kingdom
Southampton
SO16 6YD
United Kingdom
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
London
SW17 0QT
United Kingdom
South Wharf Road
London
W2 1BL
United Kingdom
Oxford Road
Stokenchurch
High Wycombe
HP14 3SX
United Kingdom
Coventry
CV2 2DX
United Kingdom
Brighton
BN2 5BE
United Kingdom
Sponsor information
Hospital/treatment centre
500 North Bristol Park
Northway
Filton
Bristol
BS34 7QH
England
United Kingdom
| Phone | +44 (0)7590352169 |
|---|---|
| research.office@nhsbt.nhs.uk | |
| Website | http://www.nhsbt.nhs.uk/ |
"ROR" |
https://ror.org/0227qpa16 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Local government
- Alternative name(s)
- National Health Service Blood and Transplant, UK National Health Service Blood and Transplant, NHSBT
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- MOD
- Location
- United Kingdom
No information available
No information available
No information available
No information available
No information available
No information available
No information available
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 01/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal, at scientific conferences and publication on (study) website |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.1 | 03/05/2022 | 02/12/2022 | No | No |
| HRA research summary | 20/09/2023 | No | No | ||
| Protocol article | RCT protocol | 14/11/2023 | 16/11/2023 | Yes | No |
| Protocol article | Implementation study protocol | 05/02/2024 | 06/02/2024 | Yes | No |
Additional files
Editorial Notes
17/03/2025: The following changes were made:
1. The recruitment end date was changed from 15/12/2024 to 12/09/2024.
2. The study contacts were updated.
06/02/2024: Publication reference added.
16/11/2023: Publication reference added.
20/09/2023: A link to the HRA research summary was added.
18/11/2022: Trial's existence confirmed by the NIHR.
