SWiFT Canada (Study of Whole Blood in Frontline Trauma) (SWiFTCanada)

SWiFT Canada (Study of Whole Blood in Frontline Trauma): A Pilot Randomized Controlled Trial Assessing Prehospital Whole Blood Versus Component Therapy in Traumatic Hemorrhage

Traumatic injuries affect people of all ages, races, and socioeconomic backgrounds. The Global Burden of Disease study showed that globally in 2019, there were more than 4.4 million deaths due to injury. Furthermore, unintentional injuries are the leading cause of death for people aged 5-29 years worldwide. Uncontrolled bleeding accounts for a significant proportion of these deaths, with approximately 20% occurring in the first 24 hours and 40% occurring within the first 30 days.

Blood transfusion is a life-saving treatment in the management of bleeding patients until bleeding is controlled in hospital, typically delivered through different blood components (red blood cells, plasma and platelets). These components are derived from a whole blood donation and are stored in separate bags (units). There are challenges in carrying separate blood products, such as additional weight in kit bags, and transfusing multiple blood products at the scene can delay transport to hospital.

In Ontario, Ornge Air Ambulance carries red blood cells and plasma to transfuse prehospital. However, a prehospital transfusion strategy has not been established and practice varies across the Canadian setting, and more broadly across the world.

This trial aims to investigate if carrying and transfusing two units of whole blood instead of four units (two red blood cells and two plasma) is feasible and leads to better outcomes for patients.

Study Overview

• Status: Recruiting
• Conditions: Trauma
• Intervention / Treatment: Biological: Whole Blood; Biological: RBC + plasma

Detailed Description

Early blood transfusion improves survival in patients with life-threatening bleeding, but the optimal transfusion strategy in the prehospital setting has yet to be established. Although there is some evidence of benefit with the use of Whole Blood (WB), there have been no RCTs exploring the clinical effectiveness of prehospital administration of WB versus component therapy for bleeding trauma patients in the Canadian setting. The lack of high-quality clinical evidence is recognized in the recent NAC recommendations for the use of WB in Canada.

In collaboration with the SWiFT UK team, the SWiFT Canada study will follow the SWiFT UK protocol but as adopted for the Canadian context. This may allow for future comparisons on effectiveness of the two systems and pilot the ability for two countries with different prehospital systems to be able to follow a similar study protocol for future international RCTs.

Lastly, we have confirmed the support from CBS for the manufacturing and distribution of WB for the duration of the SWiFT Canada trial. Therefore, it is essential for patients, healthcare professionals and blood services that the clinical effectiveness of prehospital WB transfusion is evaluated in a trial before its widespread implementation across CBS in Canada. A national program of WB production would necessitate significant changes in the current manufacturing processes for blood services, in order to provide appropriate support for hospitals. WB production could potentially affect the supply of blood components required to treat other patients, as a unit of WB cannot be used to manufacture other components. However, it could also be argued that early transfusion of WB may reduce the need for further blood component transfusion when patients arrive at hospital, due to earlier control of bleeding. Following the proposed objectives of this pilot RCT would enable us to evaluate all these uncertainties and assist in the planning of a future larger RCT.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: SWiFT Canada; Phone Number: 437 778 2260; Email: swift@unityhealth.to
• Study Contact Backup: Name: Melissa McGowan; Phone Number: 437 778 2260; Email: melissa.mcgowan@unityhealth.to

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Recruiting
      • Ornge Air Ambulance
      • Contact: Brodie Nolan, MD MSc; Phone Number: 1.800.251.6943; Email: bnolan@ornge.ca
      • Principal Investigator: Brodie Nolan, MD MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient who has suffered a traumatic injury
• Attended by a participating Ornge AAS clinical team
• Requires prehospital blood transfusion to treat major traumatic hemorrhage

Exclusion Criteria:

• Pediatric (age <16 or transported to pediatric trauma centre [if age unknown])
• 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 Ornge AAS

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Whole Blood (WB); The use of Whole Blood (WB), leukocytes reduced is indicated for treatment of patients with clinically significant bleeding and have low anti-A and anti-B titres. Patients will be administered up to 2 units of whole blood administered via either intravenous (IV) or intraosseous (IO) route, according to standard practice at Ornge AAS.	Biological: Whole Blood; 2 units of whole blood administered by Ornge AAS
Active Comparator: Red Blood Cells and Plasma; The control arm will consist of 2 units of RBC and 2 units of plasma (dependent on the standard practice of the Ornge AAS). RBC and plasma may be administered via either the intravenous (IV) or intraosseous (IO) route, according to standard clinical practice at Ornge AAS.	Biological: RBC + plasma; 2 units of RBC + 2 units of plasma administered by Ornge AAS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients enrolled in the study that receive a prehospital transfusion and had full study data collected	Feasibility target: >90% patients enrolled were able to link prehospital to in-hospital records and >90% complete data obtained	through study completion, up to 90 days
Number of patients that completed transfusion of at least 1 unit of assigned blood products prior to arrival to receiving lead trauma hospital	Feasibility target: at least 1 unit of blood [WB, RBC, or plasma] transfused prior to arrival >90% of the time	Enrolment to day 1 after enrolment
Number of patients that completed transfusion of all assigned blood products at the receiving lead trauma hospital	Feasibility target: >90% if not already done prior to arrival of hospital	Enrolment to day 1 after enrolment
Number of patients screened for the study by not randomized due to lack of group O negative WB availability.		through study completion, an average of 1 year
To describe the distribution, redistribution and wastage of WB units produced for the study	Feasibility target: <10% wastage of WB units produced for the study	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death or Massive Transfusion at 24hrs	To determine the impact of prehospital administration of WB on the proportion of participants who experience death or massive transfusion at 24 hours, compared to the current standard of care (component blood therapy).	through study completion, up to 90 days
Mortality - 90 days	To determine the impact on mortality up to 90 days.	through study completion, up to 90 days
Mortality - 30 days	To determine the impact on morbidity up to 30 days.	through study completion, up to 90 days
Organ Failure Free Days	To determine the impact of organ failure free days (hospital resource use) up to discharge	through study completion, up to 90 days
Critical Care Days	To determine the impact of time spent in critical care (hospital resource use) up to discharge	through study completion, up to 90 days
Total in-patient stay	To determine the impact on total in-patient stay (hospital resource use) up to discharge	through study completion, up to 90 days
Blood components received	To determine the impact on blood components received (hospital resource use) up to discharge	through study completion, up to 90 days
Hemostatic agents received	To determine the impact additional hemostatic agents received (hospital resource use) up to discharge	through study completion, up to 90 days
treatment-emergent adverse events	To assess the safety and tolerability of prehospital transfusion by the incidence of treatment-emergent transfusion adverse events.	through study completion, up to 90 days

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Collaborators: Sunnybrook Health Sciences Centre; Hamilton Health Sciences Corporation; London Health Sciences Centre; Canadian Blood Services; Health Sciences North; Veteran Affairs Canada; Ornge; Kingston Health Sciences Centre
• Investigators: Principal Investigator: Brodie Nolan, MD MSc, Unity Health Toronto

Publications and helpful links

General Publications

• Lin Y, Peddle M, Callum J, Beckett A, da Luz LT, Drennan I, Pavenski K, Mack J, McGowan M, Ahghari M, Smith J, Green L, Keown-Stoneman CDG, Nolan B; SWiFT Canada Investigators. Study protocol for a pilot randomised controlled trial assessing prehospital whole blood versus component therapy in traumatic haemorrhage: SWiFT Canada (study of whole blood in frontline trauma). BMJ Open. 2025 Dec 31;15(12):e108570. doi: 10.1136/bmjopen-2025-108570.

Helpful Links

• SWiFT Canada Study Site

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: June 5, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: transfusion; emergency medicine; prehospital; major hemorrhage
• Additional Relevant MeSH Terms: Wounds and Injuries; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cell Count; Cytological Techniques; Hematologic Tests; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Blood Cell Count; Erythrocyte Count
• Other Study ID Numbers: CTO-4921

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Publish study protocol, including statiscal analysis plan, informed consent process
• IPD Sharing Time Frame: Starting in September 2024, protocol will be available.
• IPD Sharing Access Criteria: Please contact the trial leadership at swift@unityhealth.to
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No