← Back to Search

Blood Product

LTOWB + TXA for Hemorrhagic Shock (MATIC-2 Trial)

Phase 3
Waitlist Available
Led By Philip C Spinella, MD
Research Sponsored by Philip Spinella
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Children, defined as less than 18 years of age with traumatic injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6, 72 hours and 28 days
Awards & highlights
Pivotal Trial

Summary

This trial aims to enroll children under 18 with severe bleeding who may need a lot of blood transfusions. They want to see if using low titer group O whole blood is better than component therapy

Who is the study for?
The MATIC-2 trial is for children under 18 with traumatic injuries and signs of severe bleeding, like low blood pressure or fast heart rate for their age. They must be suspected to need a massive transfusion due to life-threatening hemorrhage.
What is being tested?
This study tests if Low Titer Group O Whole Blood (LTOWB) or Tranexamic Acid (TXA) can lower the risk of death within 24 hours better than standard component therapy (CT) or placebo in kids with serious trauma and bleeding.
What are the potential side effects?
Possible side effects may include allergic reactions, increased clotting risks from TXA, and complications related to blood transfusions such as infection or immune response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child is under 18 and has a traumatic injury.
Select...
I have had a severe injury with significant bleeding.
Select...
My blood pressure is very low for my age.
Select...
My heart beats faster than usual for my age.
Select...
I have or might have life-threatening bleeding from an injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6, 72 hours and 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6, 72 hours and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
24 hours total blood product transfusion volumes
6-hour, 72-hour and 28-day survival

Awards & Highlights

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

Trial Design

4Treatment groups
Experimental Treatment
Group I: Group 4 (CT+Placebo)Experimental Treatment2 Interventions
Concurrent administration of CT and Placebo
Group II: Group 3 (TXA+CT)Experimental Treatment2 Interventions
Concurrent administration of TXA and CT
Group III: Group 2 (LTOWB+Placebo)Experimental Treatment2 Interventions
Concurrent administration of LTOWB and Placebo
Group IV: Group 1 (LTOWB+TXA)Experimental Treatment2 Interventions
Concurrent administration of LTOWB and TXA.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Tranexamic Acid (TXA)
2018
Completed Phase 4
~400

Find a Location

Who is running the clinical trial?

Philip SpinellaLead Sponsor
1 Previous Clinical Trials
1,000 Total Patients Enrolled
Biomedical Advanced Research and Development AuthorityFED
93 Previous Clinical Trials
552,718 Total Patients Enrolled
Philip C Spinella, MDPrincipal InvestigatorUnivesrity of Pittsburgh
2 Previous Clinical Trials
1,150 Total Patients Enrolled
~667 spots leftby Jun 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top