Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000719437
Ethics application status
Approved
Date submitted
14/10/2024
Date registered
7/07/2025
Date last updated
20/07/2025
Date data sharing statement initially provided
7/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Study of pre-hospital whole blood transfusion in frontline trauma in Aotearoa New Zealand, comparing platelet-rich whole blood versus platelet-poor whole blood in major traumatic haemorrhage
Scientific title
Study of Whole Blood in Frontline Trauma in Aotearoa: A randomized controlled feasibility study assessing Prehospital Platelet-Rich Whole Blood versus Platelet-Poor Whole Blood in Major Traumatic Haemorrhage
Secondary ID [1] 313187 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SWiFT Aotearoa
Linked study record
EudraCT: 2021-006876-18 is the original trial upon which this trial is based. We were originally going to participate in this trial but, due to much faster than expected recruitment in the UK, NZ and Canada were not able to join.

Health condition
Health condition(s) or problem(s) studied:
Traumatic haemorrhage 335474 0
Condition category
Condition code
Injuries and Accidents 332035 332035 0 0
Other injuries and accidents
Emergency medicine 332036 332036 0 0
Resuscitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Platelet-rich whole blood is defined as having >50% of post-filtration platelet content at expiry. The actual platelet content varies depending on the blood donor.

Transfusion of platelet-rich whole blood in pre-hospital traumatic haemorrhage will follow Northern Rescue Helicopter's standard clinical practice as outlined in Appendix 3 & 4. The protocol outlines the use of the ABC score to identify patients in haemorrhagic shock. The rate is as fast as possible, given that the patient is in shock. The HEMS team has an extensive record keeping system that will be used for data in the trial. No additional blood components are available pre-hospital for transfusion. Northern Rescue Helicopter already have a clinical record keeping system for pre-hospital care and this will be reviewed as part of the trial.

One or both units will be transfused prehospital with any remaining blood from the two units transfused on arrival at the hospital.

Administration of the blood in the prehospital environment will be by team comprising of a Prehospital and retrieval medicine doctor and a critical care paramedic.
Intervention code [1] 329759 0
Treatment: Other
Comparator / control treatment
Transfusion of platelet-poor whole blood in pre-hospital traumatic haemorrhage will follow Northern Rescue Helicopter's standard clinical practice as outlined in Appendix 3 & 4. This will be conducted in the same as for the intervention. The protocol outlines the use of the ABC score to identify patients in haemorrhagic shock. The rate is as fast as possible, given that the patient is in shock. No additional blood components are available pre-hospital for transfusion. Northern Rescue Helicopter already have a clinical record keeping system for pre-hospital care and this will be reviewed as part of the trial.

Platelet-poor whole is a unit of donated blood that has been filtered with a standard leucodepletion filter. This removes 99.9% of the white cells and platelets. The unit is therefore effectively red cells and plasma. This form of whole blood is a registered blood product (https://www.nzblood.co.nz/assets/Transfusion-Medicine/PDFs/112S002.pdf)
Control group
Active

Outcomes
Primary outcome [1] 339636 0
To assess the number of patients that completed transfusion of all initiated blood product transfusions
Timepoint [1] 339636 0
On arrival at hospital
Primary outcome [2] 339635 0
The second primary outcome is to assess the number of enrolled patients that completed transfusion of at least 1 unit of assigned blood products prior to arrival to receiving trauma hospital.
Timepoint [2] 339635 0
On arrival at hospital
Primary outcome [3] 339634 0
The first primary outcome is a combined outcome to assess the proportion of participants enrolled in the study that receive a prehospital transfusion and had full study data collected
Timepoint [3] 339634 0
The primary timepoint for this measure will be 90 days after transfusion for each patient.
Secondary outcome [1] 449139 0
To determine the number of recipients in each study arm who have received a massive transfusion (greater than 10 units of red cells) by 24 hours
Timepoint [1] 449139 0
End of trial
Secondary outcome [2] 449137 0
Number of days when study components (WB or PRWB, as randomised) were not available from the Blood Service (i.e. constraints in the Blood Service system)
Timepoint [2] 449137 0
End of trial
Secondary outcome [3] 449138 0
To describe the distribution of PRWB units produced for the study
Timepoint [3] 449138 0
End of trial
Secondary outcome [4] 449140 0
To determine transfusion recipient mortalities in the first 24 hours, in the first 30 days and in the first 90 days
Timepoint [4] 449140 0
Individual recipient will be assessed within 120 days of transfusion; the overall rate per component type will be assessed at the end of the trial
Secondary outcome [5] 449141 0
To determine the impact on hospital resource use up to discharge (a composite outcome), including: a. organ failure free days b. time spent in critical care c. total in- patient stay d. blood components received in hospital e. additional haemostatic agents received in hospital. Organ failure free days are defined as days not requiring ventilation, ECMO or dialysis. Additional haemostatic agents are defined as tranexamic acid (TXA), prothrombin complex concentrates (PCCs) and Factor VIIa
Timepoint [5] 449141 0
This will be assessed for each transfusion recipient within 120 days of transfusion, with overall per component data at the end of the trial
Secondary outcome [6] 449444 0
To describe the redistribution of PRWB units produced for the study
Timepoint [6] 449444 0
End of trial
Secondary outcome [7] 449136 0
Number of events where more than one patient needs blood transfused (for example major incident) and whether they were able to receive a transfusion. (i.e. constraints in prehospital system)
Timepoint [7] 449136 0
End of trial
Secondary outcome [8] 449445 0
To describe the wastage of PRWB units produced for the study
Timepoint [8] 449445 0
End of trial
Secondary outcome [9] 449142 0
To assess safety of prehospital transfusion by documenting all transfusion reactions/events within the first 14 days after randomization and explore any different rates/types of transfusion reactions between patients who received PRWB vs WB
Timepoint [9] 449142 0
This will be assessed midpoint during the trial as a safety signal and at the end of the trial

Eligibility
Key inclusion criteria
1. Patient who has suffered trauma
2. Attended by a participating Northern Rescue clinical team
3. Requires prehospital blood transfusion to treat traumatic haemorrhagic shock
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. No intravenous or intraosseous access (should be assessed prior to opening box)
2. Knowledge that patient will object to being given blood transfusion for any reasons
3. Blood already administered on-scene, prior to arrival of Northern Rescue
4. Patients experiencing non-traumatic haemorrhage

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealment is conducted by the blood bank providing the whole blood by applying labels over the component type identifiers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple block (block of four) randomisation sequence for either PRWB or WB was generated using https://www.sealedenvelope.com. This was converted into physical sealed envelopes for Blood Bank to open. REDCap will make use of the same list. No-one directly involved in the trial has seen or has access to the sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/07/2025
Actual
Date of last participant enrolment
Anticipated
27/07/2029
Actual
Date of last data collection
Anticipated
31/01/2030
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 26634 0
New Zealand
State/province [1] 26634 0
Auckland and Northland

Funding & Sponsors
Funding source category [1] 317634 0
Government body
Name [1] 317634 0
New Zealand Blood Service
Country [1] 317634 0
New Zealand
Funding source category [2] 317635 0
Charities/Societies/Foundations
Name [2] 317635 0
Northern Rescue Helicopters
Country [2] 317635 0
New Zealand
Primary sponsor type
Government body
Name
New Zealand Blood Service
Address
Country
New Zealand
Secondary sponsor category [1] 319946 0
None
Name [1] 319946 0
Address [1] 319946 0
Country [1] 319946 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316333 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 316333 0
Ethics committee country [1] 316333 0
New Zealand
Date submitted for ethics approval [1] 316333 0
06/06/2025
Approval date [1] 316333 0
17/06/2025
Ethics approval number [1] 316333 0
2025 FULL 23080

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137558 0
Dr Richard Charlewood
Address 137558 0
New Zealand Blood Service, Private Bag 92071, Auckland 1142
Country 137558 0
New Zealand
Phone 137558 0
+64 95235733
Fax 137558 0
Email 137558 0
[email protected]
Contact person for public queries
Name 137559 0
Richard Charlewood
Address 137559 0
New Zealand Blood Service, Private Bag 92071, Auckland 1142
Country 137559 0
New Zealand
Phone 137559 0
+64 95235733
Fax 137559 0
Email 137559 0
[email protected]
Contact person for scientific queries
Name 137560 0
Richard Charlewood
Address 137560 0
New Zealand Blood Service, Private Bag 92071, Auckland 1142
Country 137560 0
New Zealand
Phone 137560 0
+64 95235733
Fax 137560 0
Email 137560 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers conducting a sound meta-analysis

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified data for the purpose of a meta-analysis

What types of analyses could be done with individual participant data?
• Meta-analysis of similar trials of platelet-rich whole blood

When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
A finite period of: 10 years
Where can requests to access individual participant data be made, or data be obtained directly?
• The principal investigator via [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol    SWIFT Aotearoa Feasibility RCT Protocol v3_06Jun25_Final_clean.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.