60 Participants Needed

Whole Blood for Trauma

(SWiFTCanada Trial)

SC
MM
Overseen ByMelissa McGowan
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Unity Health Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of 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.

Research Team

BN

Brodie Nolan, MD MSc

Principal Investigator

Unity Health Toronto

Eligibility Criteria

The SWiFT Canada trial is for patients who have experienced a traumatic injury and need blood transfusion before reaching the hospital. They must be attended by an Ornge Air Ambulance Service (AAS) clinical team involved in the study.

Inclusion Criteria

I have had a traumatic injury.
I am being cared for by a team involved in the Ornge AAS study.
I needed a blood transfusion before hospital for major bleeding due to injury.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive prehospital transfusion of either whole blood or component therapy (red blood cells and plasma) according to the trial arm they are assigned to.

Up to 1 day
1 visit (prehospital)

Follow-up

Participants are monitored for safety and effectiveness, including treatment-emergent adverse events and mortality, up to 90 days.

90 days

Data Collection and Analysis

Data on transfusion feasibility, safety, and outcomes are collected and analyzed.

Through study completion, up to 1 year

Treatment Details

Interventions

  • Whole Blood
Trial Overview This study tests whether giving two units of whole blood is more effective than four separate units (two red blood cells, two plasma) for prehospital treatment of major bleeding due to trauma.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Whole Blood (WB)Experimental Treatment1 Intervention
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.
Group II: Red Blood Cells and PlasmaActive Control1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials
572
Recruited
470,000+

Health Sciences North

Collaborator

Trials
6
Recruited
1,100+

Canadian Blood Services

Collaborator

Trials
24
Recruited
39,200+

Ornge

Collaborator

Trials
1
Recruited
60+

Veteran Affairs Canada

Collaborator

Trials
1
Recruited
60+

London Health Sciences Centre

Collaborator

Trials
151
Recruited
60,400+

Queen's University

Collaborator

Trials
382
Recruited
122,000+

Sunnybrook Health Sciences Centre

Collaborator

Trials
693
Recruited
1,569,000+

Hamilton Health Sciences Corporation

Collaborator

Trials
380
Recruited
345,000+

Kingston Health Sciences Centre

Collaborator

Trials
312
Recruited
112,000+
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