For investigators

Information for investigators around trial design, criteria and outcomes.

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Study design

This is a phase III multi-centre, interventional, randomised, unblinded, parallel controlled clinical trial of an Investigational Medicinal Product (CTIMP).

Participants will be randomised 1:1 to intervention and comparator.

Eligibility criteria

Participant inclusion criteria:

  • patient (of any age) who has suffered a traumatic injury
  • attended by a participating Air Ambulance Service (AAS) clinical team
  • requires pre-hospital blood transfusion to treat major traumatic haemorrhage

Participant exclusion criteria:

  • No intravenous or intraosseous access (should be assessed prior to opening box)
  • Knowledge that patient will object to being given blood transfusion for any reasons
  • Blood already administered on-scene, prior to arrival of the participating AAS

Primary outcomes

The primary outcome measure is 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 outcomes

Clinical outcomes

  • Individual components of the primary outcome: Proportion of participants who:
    • Experienced all-cause mortality at 24 hours from randomisation
    • Received a total of 10 or more units of any blood components in the first 24 hours of randomisation
  • All-cause mortality within 6 hours and separately 30 and 90 days of randomisation
  • 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:
    • Number of days free of advanced respiratory support
    • Number of days free of advanced cardiovascular support
    • Number of days free of advanced renal support
  • Days in critical care and separately in an acute care hospital (up to 90 days)
  • Units of each blood component received in the 24 hours after randomisation (including prehospital transfusions): WB, RBC, plasma, platelets and cryoprecipitate
  • Amount of cell salvage received at 24 hours (in mLs) after randomisation
  • Number of participants receiving additional haemostatic agents received at 24 hours after randomisation: recombinant Factor VIIa, fibrinogen concentrate, prothrombin complex concentrate (PCC), tranexamic acid (TXA)
  • 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
  • Acid-base disturbance measured by lactate, base excess and pH level in first sample taken on arrival at acute care hospital

Cost-effectiveness analysis outcomes

  • Incremental cost of the whole blood intervention.
  • Hospital resource use to discharge or death.
  • Health, social and wider care resource use to 90 days after randomisation.
  • Health-related quality of life as measured by EQ-5D-5L at 90 days after randomisation.


Please see below for details about trial co-enrolment with SWiFT. If you'd like to enquire about a trial currently not listed here, please email the SWiFT trial team.

Trials that can be co-enrolled

Trials that cannot be co-enrolled