SWiFT Canada (Study of Whole Blood in Frontline Trauma)
NCT Number: NCT06495294
Acronym: SWiFTCanada
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Trauma
Interventions: BIOLOGICAL: Whole Blood|BIOLOGICAL: RBC + plasma
Sponsor: Unity Health Toronto
Collaborators: Veteran Affairs Canada|Ornge|Canadian Blood Services|Sunnybrook Health Sciences Centre|Hamilton Health Sciences Corporation|London Health Sciences Centre|Queen's University|Health Sciences North
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-06

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.

Primary Outcome Measures: 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: 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