← Back to Search

Blood Product

Low Titer Whole Blood for Hemorrhagic Shock (TOWAR Trial)

Phase 3

Recruiting

Led By Jason L Sperry, MD

Research Sponsored by Jason Sperry

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Injured patients at risk of hemorrhagic shock being transported from scene or referral hospital to a participating TOWAR trial site that meet requirements for initiation of blood or blood component transfusion

Systolic blood pressure ≤ 90mmHg and tachycardia (HR ≥ 108) at scene, at outside hospital or during transport

Must not have

Inability to obtain IV or intraosseous access

Isolated burns without evidence of traumatic injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment time to first transfusion

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial aims to compare the efficacy and safety of low titer whole blood resuscitation to standard care resuscitation for patients at risk of hemorrhagic shock.

Who is the study for?

This trial is for people with severe injuries at risk of hemorrhagic shock who have very low blood pressure. It's open to adults aged 18-90, not including pregnant individuals, prisoners, or those with specific types of brain injuries and other exclusions like drowning or hanging victims without other trauma.

What is being tested?

The study compares the effectiveness and safety of using low titer whole blood versus standard care in pre-hospital settings for patients at risk of bleeding out. It involves multiple trauma centers and looks at how well the donated blood works based on its age.

What are the potential side effects?

While specific side effects are not listed, transfusions can cause allergic reactions, fever, lung injury, iron overload in long-term cases, infections from transmitted diseases (rare), and complications from mismatched blood types.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am at risk of severe bleeding and being taken to a hospital for a blood transfusion.

Select...

My blood pressure was 90 or lower and my heart rate was 108 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

Doctors cannot use veins or bones for my treatments.

Select...

I have burns without any other injuries.

Select...

I have an injury that exposed my brain or was caused by a gunshot.

Select...

I am between 18 and 90 years old.

Select...

I had a traumatic arrest and received CPR for more than 5 minutes without my vital signs returning.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment through 60 minutes and 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment through 60 minutes and 24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment through 60 minutes and 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

30-day mortality

Secondary study objectives

24-hour mortality

3-hour mortality

6-hour mortality

+17 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Whole BloodExperimental Treatment1 Intervention

Subjects will receive up to two units of whole blood as collected by local blood bank procedures and stored at 1-6 degrees Celsius initiated in the prehospital phase of care.

Group II: Standard CareActive Control1 Intervention

Subjects will receive prehospital crystalloid infusion or blood component transfusion resuscitation per site standard care for the respective Emergency Medical unit/service.

0 / 7Eligibility criteria met