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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment through 60 minutes and 24 hours
Awards & highlights

TOWAR Trial 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.Check my eligibility
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.See study design
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.

TOWAR Trial 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.

TOWAR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment time to first transfusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment time to first transfusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
30-day mortality
Secondary outcome measures
24-hour mortality
3-hour mortality
6-hour mortality
+17 more

TOWAR 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.

Find a Location

Who is running the clinical trial?

Jason SperryLead Sponsor
8 Previous Clinical Trials
5,865 Total Patients Enrolled
United States Department of DefenseFED
858 Previous Clinical Trials
224,601 Total Patients Enrolled
Jason L Sperry, MDPrincipal InvestigatorUniversity of Pittsburgh
2 Previous Clinical Trials
620 Total Patients Enrolled

Media Library

Low Titer Whole Blood (Blood Product) Clinical Trial Eligibility Overview. Trial Name: NCT04684719 — Phase 3
Hemorrhagic Shock Research Study Groups: Whole Blood, Standard Care
Hemorrhagic Shock Clinical Trial 2023: Low Titer Whole Blood Highlights & Side Effects. Trial Name: NCT04684719 — Phase 3
Low Titer Whole Blood (Blood Product) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04684719 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can people who are over 30 years old participate in this research project?

"Eligibility for this study appears to be restricted to those aged 18-89."

Answered by AI

Are new patients able to join this clinical trial?

"Correct, the clinicaltrials.gov listing for this study confirms that it is actively recruiting participants. The trial was first posted on 4/19/2022 and was last updated on 9/24/2022. The study is looking for 1020 participants at 2 sites."

Answered by AI

Is it dangerous to receive low titer whole blood transfusions?

"While there are Phase 2 trial data supporting the safety of low titer whole blood, there is currently no information regarding its efficacy. As such, our team has given it a score of 2."

Answered by AI

Which patients would be a good match for this type of clinical research?

"Patients that wish to enroll in this study must have experienced shock and hemorrhagic, be between 18-89 years old. Currently, the trial is seeking a total of 1020 participants."

Answered by AI

How many individuals are included in this research project?

"The most recent information available on clinicaltrials.gov affirms that this study is still looking for patients. This particular trial was first posted on 4/19/2022 and was updated as recently as 9/24/2022. They are hoping to enroll 1020 people at 2 locations."

Answered by AI
~403 spots leftby Jul 2025