The effect of the proportion of low-titer O whole blood for resuscitation in pediatric trauma patients on 6-, 12- and 24-hour survival.
Ethan M Petersen, Andrew D Fisher, Michael D April...
https://pubmed.ncbi.nlm.nih.gov/39898869Actively Recruiting
Phase 3
Age: 0 - 17Years
All Genders
ID06070350
Massive Transfusion in Children: a Platform RCT of Whole Blood Compared to Component Therapy and Tranexamic Acid to Placebo in Life-threatening Traumatic Bleeding
Led by Philip Spinella · Updated on 2026-05-11
1000
Participants Needed
23
Research Sites
17 weeks
Total Duration
On this page
Sponsors
P
Philip Spinella
Lead Sponsor
B
Biomedical Advanced Research and Development Authority
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting the MATIC-2 trial, a multicenter phase III study, to evaluate treatments for children under 18 years old experiencing hemorrhagic shock from traumatic injury who may need large blood transfusions. The study aims to compare the effectiveness of Low Titer Group O Whole Blood (LTOWB) versus component therapy (CT), and Tranexamic Acid (TXA) versus placebo, in reducing death from any cause within 24 hours after injury. The trial also assesses safety outcomes such as organ failure, infections, and thrombotic events, as well as explores how treatments affect trauma-induced blood clotting problems and TXA drug properties in children. Participants will be randomly assigned to one of four groups receiving concurrent treatments: LTOWB with TXA, LTOWB with placebo, CT with TXA, or CT with placebo. LTOWB involves transfusing whole blood from group O donors with low antibody levels, while CT uses separate blood components in a 1:1:1 ratio. TXA is given intravenously or intraosseously at a dose based on body weight. The study excludes children with devastating brain injuries, those who had CPR for over 5 minutes before treatment, or those who received TXA before enrollment. Treatment is delivered during active life-threatening bleeding under a massive transfusion protocol. During the trial, children will be monitored for survival at 6 hours, 24 hours, 72 hours, and 28 days, along with blood transfusion volumes. Researchers will evaluate adverse events like kidney injury, respiratory distress, stroke, and infections. Blood samples and clinical data will be collected to understand blood clotting and immune responses. The study involves careful safety monitoring and aims to improve trauma resuscitation in pediatric patients. Participation duration varies depending on follow-up and treatment responses.
CONDITIONS
Brief Title
Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children
Who Can Participate
Age: 0 - 17Years
All Genders
Eligibility Criteria
You may qualify if you...
- Children under 18 years old with traumatic injury
- Activation of massive transfusion protocol for confirmed or suspected life-threatening bleeding
- Confirmed or suspected active life-threatening bleeding with at least two of the following: low blood pressure for age, high heart rate for age, severe bleeding signs such as penetrating injury or hemothorax
You will not qualify if you...
- Devastating traumatic brain injury unlikely to survive (e.g., transhemispheric gunshot wound with herniation, GCS score of 3 with fixed dilated pupils)
- Massive transfusion protocol activated but no blood products given
- Needed emergency thoracotomy or received more than 5 minutes of CPR before blood products
- Known or suspected pregnancy
- Known prisoners
- Ward of the state
- Isolated hanging, drowning, or burns
- Previous enrollment in MATIC-2
- Prior study opt-out with bracelet
- Use of Tranexamic Acid before enrollment
- More than 3 hours since injury
- History of seizure after injury
- Known allergy to Tranexamic Acid
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - Up to 3 hours since injury
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (emergency setting)
Treatment
Duration - Treatment during active hemorrhage and transfusion period
Participants receive randomized treatment with either Low Titer Group O Whole Blood (LTOWB) or Component Therapy (CT), combined with Tranexamic Acid (TXA) or placebo to manage life-threatening traumatic hemorrhage.
Treatment administered as part of emergency care with interventions concurrent during transfusion
Follow-up
Duration - Up to 28 days post-treatment
Participants are monitored for survival, safety outcomes, and adverse events including kidney injury, respiratory distress, thrombotic events, and infection up to 28 days after treatment.
Assessments at 6 hours, 24 hours, 72 hours, and 28 days post-treatment
Trial Site Locations
Total: 23 locations
1
University of Arizona
Tucson, Arizona, United States, 84719
Actively Recruiting
2
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Actively Recruiting
3
University of California Davis
Sacramento, California, United States, 95817
Actively Recruiting
4
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
5
Emory University-Arthur M. Blank Hospital
Atlanta, Georgia, United States, 30329
Actively Recruiting
6
Emory University-Scottish Rite Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
7
Tulane School of Medicine
New Orleans, Louisiana, United States, 70118
Actively Recruiting
8
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Actively Recruiting
9
Washington University of St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
10
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
11
Wake Forest University Health Sciences
Wake Forest, North Carolina, United States, 27157
Actively Recruiting
12
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
13
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
14
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
15
LeBonheur Children's Hospital
Memphis, Tennessee, United States, 38103
Actively Recruiting
16
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Not Yet Recruiting
17
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
18
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
19
Children's Memorial Hermann Hospital
Houston, Texas, United States, 77030
Actively Recruiting
20
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
21
Primary Children's Hospital
Salt Lake City, Utah, United States, 84112
Actively Recruiting
22
University of Washington Harborview
Seattle, Washington, United States, 98195
Actively Recruiting
23
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Loading map...
Research Team
J
Jane Luce
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here