Recruiting

Whole Blood

Sponsor:

Unity Health Toronto

Code:

NCT06495294

Conditions

Trauma

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

Whole Blood

RBC + plasma

Study Details

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.

Conditions

Trauma

Study ID

NCT06495294

Start date

Dec 16, 2024

Status verified date

Apr, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Whole Blood (WB)

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.

active comparator: Red Blood Cells and Plasma

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.

Interventions

Whole Blood

2 units of whole blood administered by Ornge AAS

RBC + plasma

2 units of RBC + 2 units of plasma administered by Ornge AAS

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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Locations

Ornge Air Ambulance

Recruiting

Toronto, Ontario, Canada

Contacts

Brodie Nolan, MD MSc

1.800.251.6943bnolan@ornge.ca

Principal Investigator:

Brodie Nolan, MD MSc

More Information

Sponsor

Unity Health Toronto

Last update posted

May 6, 2026

Last verified

Apr, 2026

Keywords

  • prehospital
  • major hemorrhage
  • transfusion
  • emergency medicine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2026-05-06.