SWiFT Canada (Study of Whole Blood in Frontline Trauma)
ConditionTrauma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorUnity Health Toronto
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient who has suffered a traumatic injury
Attended by a participating Ornge AAS clinical team
Requires prehospital blood transfusion to treat major traumatic hemorrhage
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Whole Blood
Biological/Vaccine2 units of whole blood administered by Ornge AAS
RBC + plasma
Biological/Vaccine2 units of RBC + 2 units of plasma administered by Ornge AAS
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Whole Blood (WB)Experimental treatment 1 intervention
Group B: Red Blood Cells and PlasmaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
through study completion, up to 90 days2
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
Time frame
Enrolment to day 1 after enrolment3
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
Time frame
Enrolment to day 1 after enrolment4
Number of patients screened for the study by not randomized due to lack of group O negative WB availability.
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
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).
Time frame
through study completion, up to 90 days2
Mortality - 90 days
To determine the impact on mortality up to 90 days.
Time frame
through study completion, up to 90 days3
Mortality - 30 days
To determine the impact on morbidity up to 30 days.
Time frame
through study completion, up to 90 days4
Organ Failure Free Days
To determine the impact of organ failure free days (hospital resource use) up to discharge
Time frame
through study completion, up to 90 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Unity Health Toronto
Lead sponsor
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
Source ClinicalTrials.gov