SWiFT Canada (Study of Whole Blood in Frontline Trauma)

NCT06495294 | Recruiting

• 1 other identifier: CTO-4921
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trauma

Keywords

prehospital; major hemorrhage; transfusion; emergency medicine

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (9)

• Death or Massive Transfusion at 24hrs

  through study completion, up to 90 days

• Mortality - 90 days

  through study completion, up to 90 days

• Mortality - 30 days

  through study completion, up to 90 days

• Organ Failure Free Days

  through study completion, up to 90 days

• Critical Care Days

  through study completion, up to 90 days

Study Arms (2)

Whole Blood (WB)

EXPERIMENTAL

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

Red Blood Cells and Plasma

ACTIVE COMPARATOR

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

Interventions

RBC + plasma BIOLOGICAL

2 units of RBC + 2 units of plasma administered by Ornge AAS

Red Blood Cells and Plasma

Whole Blood BIOLOGICAL

2 units of whole blood administered by Ornge AAS

Whole Blood (WB)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead
• Veteran Affairs Canada: collaborator
• Ornge: collaborator
• Canadian Blood Services: collaborator
• Sunnybrook Health Sciences Centre: collaborator
• Hamilton Health Sciences Corporation: collaborator
• London Health Sciences Centre: collaborator
• Kingston Health Sciences Centre: collaborator
• Health Sciences North: collaborator

Study Sites (1)

Ornge Air Ambulance

Toronto, Ontario, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 41475814 RESULT

Related Links

• SWiFT Canada Study Site

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Erythrocyte Count

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Brodie Nolan, MD MSc

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SWiFT Canada

CONTACT

437 778 2260; swift@unityhealth.to

Melissa McGowan

CONTACT

437 778 2260; melissa.mcgowan@unityhealth.to

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A multicentre, pragmatic, randomized controlled, open-label, parallel group two arm trial.

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: July 10, 2024
• Study Start: December 16, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting in September 2024, protocol will be available.
• Access Criteria: Please contact the trial leadership at swift@unityhealth.to

Locations

CA (1)