Whole Blood for Trauma

(SWiFTCanada Trial)

Overseen By Melissa McGowan

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Unity Health Toronto

Disqualifiers: Pediatric, No IV access, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Up to 1 day

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with severe bleeding from injuries. Researchers aim to determine if using two units of whole blood (a type of blood transfusion) is more effective than the usual method of using separate red blood cells and plasma. Whole blood may be easier and faster to administer, particularly before reaching a hospital. This study targets individuals who have sustained a serious injury and require a blood transfusion before hospital arrival. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance emergency care for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using whole blood for trauma patients is promising in terms of safety. Studies have found that whole blood transfusions significantly lower the risk of dying within the first 24 hours compared to using separate blood products like red blood cells and plasma. This is crucial because many deaths from injuries occur quickly, so early treatment can save lives.

Whole blood is generally safe for patients. No significant difference exists in the risk of dying within 30 days or while in the hospital when comparing whole blood to separate blood components. This indicates that whole blood is as safe as the traditional method of giving separate blood products.

Overall, the evidence supports the safety of whole blood transfusions in trauma care, making it a strong option for treating patients with severe bleeding. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using whole blood for trauma because it offers a more comprehensive treatment compared to the traditional method of administering separate red blood cells and plasma. Unlike standard care, whole blood can provide all the necessary components—red cells, plasma, and platelets—in one package, potentially improving outcomes for patients with significant bleeding. This approach may simplify and speed up transfusions, which is crucial in emergency situations, giving it the potential to save more lives.

What evidence suggests that whole blood is effective for treating traumatic injuries?

Research has shown that using whole blood for trauma patients can be more effective than using separate components like red blood cells and plasma. In this trial, participants will receive either whole blood or a combination of red blood cells and plasma. One study found that whole blood transfusions reduced the risk of death by 37% within the first 24 hours and by 47% after 30 days compared to using separate blood components. Another study noted that whole blood is regaining popularity because it often leads to better outcomes for trauma patients. Overall, using whole blood for injuries has been linked to improved survival rates compared to using separated blood components. ^{1 2 3 5 6}

Who Is on the Research Team?

Brodie Nolan, MD MSc

Principal Investigator

Unity Health Toronto

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Whole Blood (WB) Experimental Treatment 1 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 Plasma Active Control 1 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.

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10831629/

Timing to First Whole Blood Transfusion and Survival ... The results of the study showed that WB plus MTP was associated with a 37% and 47% lower risk of mortality at 24 hours and 30 days, respectively ...

2. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2814272

Timing to First Whole Blood Transfusion and Survival ... This cohort study examines whether the timing of whole blood transfusion is associated with improved survival among adult trauma patients ...

3. facs.org facs.org/for-medical-professionals/news-publications/news-and-articles/bulletin/2023/april-2023-volume-108-issue-4/whole-blood-in-resuscitating-trauma-patients-is-making-a-comeback/

Whole Blood in Resuscitating Trauma Patients Is Making a ... Emerging research reveals whole blood is a better option than fractionated components of blood for trauma patients.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0049384825002452

Evaluating the safety outcomes of whole blood versus ... Highlights · Compared whole blood vs. · Whole blood significantly reduced 24-h mortality (OR: 0.67). · No significant difference in 30-day or in-hospital mortality.

5. tsaco.bmj.com tsaco.bmj.com/content/9/1/e001482.info

Whole lot of blood: does more equal better for survival? 3 Prior studies evaluating the impact of whole blood in civilian trauma have demonstrated an associated survival advantage over using component ...

6. journalofsurgicalresearch.com journalofsurgicalresearch.com/article/S0022-4804(23)00056-2/fulltext

Outcomes of Transfusion With Whole Blood, Component ... Based on these findings, greater utilization of whole blood in civilian adult trauma resuscitation may lead to improved mortality and reduced ...