Clinical trial NCT06495294: SWiFT Canada (Study of Whole Blood in Frontline Trauma)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Trauma
Keywords: prehospital
major hemorrhage
transfusion
emergency medicine
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Veteran Affairs Canada
name: Ornge
name: Canadian Blood Services
name: Sunnybrook Health Sciences Centre
name: Hamilton Health Sciences Corporation
name: London Health Sciences Centre
name: Kingston Health Sciences Centre
name: Health Sciences North
First posted: 2024-07-10
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multicentre, pragmatic, randomized controlled, open-label, parallel group two arm trial.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Proportion of patients enrolled in the study that receive a prehospital transfusion and had full study data collected
timeFrame: through study completion, up to 90 days
measure: Number of patients that completed transfusion of at least 1 unit of assigned blood products prior to arrival to receiving lead trauma hospital
timeFrame: Enrolment to day 1 after enrolment
measure: Number of patients that completed transfusion of all assigned blood products at the receiving lead trauma hospital
timeFrame: Enrolment to day 1 after enrolment
measure: Number of patients screened for the study by not randomized due to lack of group O negative WB availability.
timeFrame: through study completion, an average of 1 year
measure: To describe the distribution, redistribution and wastage of WB units produced for the study
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Death or Massive Transfusion at 24hrs
timeFrame: through study completion, up to 90 days
measure: Mortality - 90 days
timeFrame: through study completion, up to 90 days
measure: Mortality - 30 days
timeFrame: through study completion, up to 90 days
measure: Organ Failure Free Days
timeFrame: through study completion, up to 90 days
measure: Critical Care Days
timeFrame: through study completion, up to 90 days
measure: Total in-patient stay
timeFrame: through study completion, up to 90 days
measure: Blood components received
timeFrame: through study completion, up to 90 days
measure: Hemostatic agents received
timeFrame: through study completion, up to 90 days
measure: treatment-emergent adverse events
timeFrame: through study completion, up to 90 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Ornge Air Ambulance
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Brodie Nolan, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: