TraumaSWiFTCanadaNCT06495294
SWiFT Canada (Study of Whole Blood in Frontline Trauma)
A study testing Whole Blood and RBC + plasma in people with Trauma, run by Unity Health Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Trauma
- What is being tested?
- Whole Blood and RBC + plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 16 Dec 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient who has suffered a traumatic injury
- Attended by a participating Ornge AAS clinical team
- Requires prehospital blood transfusion to treat major traumatic hemorrhage
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Ornge Air Ambulance
Toronto, Ontario
Brodie Nolan, MD MSc, 1.800.251.6943, bnolan@ornge.ca
Brodie Nolan, MD MSc
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Trauma
- Being tested
- Whole Blood, RBC + plasma
- Keywords
- prehospital, major hemorrhage, transfusion, emergency medicine
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole BloodBiological
2 units of whole blood administered by Ornge AAS
RBC + plasmaBiological
2 units of RBC + 2 units of plasma administered by Ornge AAS
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: RBC + plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: through study completion, an average of 1 year
Secondary outcomes (9)
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).
Measured: through study completion, up to 90 days
Mortality - 90 days
To determine the impact on mortality up to 90 days.
Measured: through study completion, up to 90 days
Mortality - 30 days
To determine the impact on morbidity up to 30 days.
Measured: 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
Measured: 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
Measured: 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
Measured: through study completion, up to 90 days
Blood components received
To determine the impact on blood components received (hospital resource use) up to discharge
Measured: through study completion, up to 90 days
Hemostatic agents received
To determine the impact additional hemostatic agents received (hospital resource use) up to discharge
Measured: 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.
Measured: through study completion, up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start16 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicentre, pragmatic, randomized controlled, open-label, parallel group two arm trial.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Veteran Affairs Canada, Ornge, Canadian Blood Services, Sunnybrook Health Sciences Centre, Hamilton Health Sciences Corporation, London Health Sciences Centre, Kingston Health Sciences Centre, Health Sciences North
- Responsible party
- Sponsor
- Investigators
- Brodie Nolan, MD MSc, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495294
- Sponsor's protocol ID
- CTO-4921
- Acronym
- SWiFTCanada
- Status last verified
- Apr 2026
- First submitted
- 5 Jun 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publish study protocol, including statiscal analysis plan, informed consent process
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.
PubMed 41475814
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SWiFT Canada (Study of Whole Blood in Frontline Trauma): A Pilot Randomized Controlled Trial Assessing Prehospital Whole Blood Versus Component Therapy in Traumatic Hemorrhage
- ClinicalTrials.gov ID
- NCT06495294
- Acronym / sponsor ID
- SWiFTCanada / CTO-4921
- Conditions
- Trauma
- Keywords
- prehospital, major hemorrhage, transfusion, emergency medicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Veteran Affairs Canada, Ornge, Canadian Blood Services, Sunnybrook Health Sciences Centre, Hamilton Health Sciences Corporation, London Health Sciences Centre, Kingston Health Sciences Centre, Health Sciences North
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A multicentre, pragmatic, randomized controlled, open-label, parallel group two arm trial.
| Arm | Type | Receives |
|---|---|---|
| Whole Blood (WB) | Experimental | Biological: Whole BloodThe 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. |
| Red Blood Cells and Plasma | Active comparator | Biological: RBC + plasmaThe 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient who has suffered a traumatic injury
- Attended by a participating Ornge AAS clinical team
- Requires prehospital blood transfusion to treat major traumatic hemorrhage
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Blood2 units of whole blood administered by Ornge AAS | Biological | Whole Blood (WB) |
| RBC + plasma2 units of RBC + 2 units of plasma administered by Ornge AAS | Biological | Red Blood Cells and Plasma |
Primary outcome
Proportion of patients enrolled in the study that receive a prehospital transfusion and had full study data collected
Time frame: through study completion, up to 90 days
Feasibility target: >90% patients enrolled were able to link prehospital to in-hospital records and >90% complete data obtained
Number of patients that completed transfusion of at least 1 unit of assigned blood products prior to arrival to receiving lead trauma hospital
Time frame: Enrolment to day 1 after enrolment
Feasibility target: at least 1 unit of blood [WB, RBC, or plasma] transfused prior to arrival >90% of the time
Number of patients that completed transfusion of all assigned blood products at the receiving lead trauma hospital
Time frame: Enrolment to day 1 after enrolment
Feasibility target: >90% if not already done prior to arrival of hospital
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 year
To describe the distribution, redistribution and wastage of WB units produced for the study
Time frame: through study completion, an average of 1 year
Feasibility target: <10% wastage of WB units produced for the study
9 secondary outcomes
Death or Massive Transfusion at 24hrs
Time frame: through study completion, up to 90 days
Mortality - 90 days
Time frame: through study completion, up to 90 days
Mortality - 30 days
Time frame: through study completion, up to 90 days
Organ Failure Free Days
Time frame: through study completion, up to 90 days
Critical Care Days
Time frame: through study completion, up to 90 days
Total in-patient stay
Time frame: through study completion, up to 90 days
Blood components received
Time frame: through study completion, up to 90 days
Hemostatic agents received
Time frame: through study completion, up to 90 days
treatment-emergent adverse events
Time frame: through study completion, up to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Results publication: PubMed 41475814Lin 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.
- SWiFT Canada Study SiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Publish study protocol, including statiscal analysis plan, informed consent process
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brodie Nolan, MD MSc principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Blood and RBC + plasma in people with Trauma, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SWiFT Canada (437 778 2260, swift@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients enrolled in the study that receive a prehospital transfusion and had full study data collected (time frame: through study completion, up to 90 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06495294, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.