Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children
MATIC-2
1 other identifier
interventional
1,000
1 country
23
Brief Summary
The MATIC-2 is a multicenter clinical trial enrolling children who are less than 18 years of age with hemorrhagic shock potentially needing significant blood transfusion. The primary objective of the clinical trial is to determine the effectiveness of Low Titer Group O Whole Blood (LTOWB) compared to component therapy (CT), and Tranexamic Acid (TXA) compared to placebo in decreasing 24-hour all-cause mortality in children with traumatic life threatening hemorrhage.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2024
Typical duration for phase_3
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2023
CompletedFirst Posted
Study publicly available on registry
October 6, 2023
CompletedStudy Start
First participant enrolled
November 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
February 23, 2026
February 1, 2026
3.6 years
September 27, 2023
February 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
24 hours all cause mortality
24 hours
Secondary Outcomes (2)
6-hour, 72-hour and 28-day survival
6, 72 hours and 28 days
24 hours total blood product transfusion volumes
24 hours
Study Arms (4)
Group 1 (LTOWB+TXA)
OTHERConcurrent administration of LTOWB and TXA
Group 2 (LTOWB+Placebo)
OTHERConcurrent administration of LTOWB and Placebo
Group 3 (CT+TXA)
OTHERConcurrent administration of CT and TXA
Group 4 (CT+Placebo)
OTHERConcurrent administration of CT and Placebo
Interventions
Component Therapy (CT) will be RBCs, plasma and platelet units in a 1:1:1 unit ratio. This will be given with Placebo
LTOWB is whole blood from group O donors with low titer (\<200) anti-A and anti-B antibodies. Up to 8 units of LTOWB will be allowed unless local clinical practice allows for a higher maximum dose.
Placebo will be provided to the research pharmacy at each of the clinical sites
TXA is a synthetic lysine analog that competitively inhibit activation of plasminogen, thereby decreasing the conversion of plasminogen to plasmin, preventing degradation of fibrin's matrix structure. Dose is 25mg/kg IV or IO (maximum 2 grams).
Eligibility Criteria
You may qualify if:
- Children, defined as less than estimated18 years of age with traumatic injury
- MTP activation for confirmed or suspected active life-threatening traumatic bleeding
- AND
- Confirmed or suspected active life-threatening traumatic bleeding with at least 2 of 3 of the following criteria:
- Hypotension for age (\< 5% tile)
- Tachycardia for age (\>95th % tile)
- Traumatic injury with exam findings consistent with severe bleeding (e.g., penetrating injury, hemothorax, distended abdomen with bruising, amputation of limb).
You may not qualify if:
- Patient with devastating traumatic brain injury not expected to survive due to magnitude of injury (example: Transhemispheric gunshot wound with signs of herniation, GCS score of 3 with fixed and dilated pupils)
- MTP activated but no blood products given
- Patients who required an ED thoracotomy or received more than 5 consecutive minutes of cardiopulmonary resuscitation (prior to receiving randomized blood products)
- Patients who are known or suspected to be pregnant on clinical examination
- Known prisoners as defined in protocol
- Known ward of the state
- Isolated hanging, drowning or burns
- Previous enrollment in MATIC-2
- Prior study opt-out with bracelet
- Prehospital or pre-enrollment use of TXA
- Greater than 3 hours since time of injury
- History of seizure after the injury event
- Known allergy or hypersensitivity reaction to TXA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
University of Arizona
Tucson, Arizona, 84719, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
University of California Davis
Sacramento, California, 95817, United States
Children's National Hospital
Washington D.C., District of Columbia, 20010, United States
Emory University-Arthur M. Blank Hospital
Atlanta, Georgia, 30329, United States
Emory University-Scottish Rite Hospital
Atlanta, Georgia, 30342, United States
Tulane School of Medicine
New Orleans, Louisiana, 70118, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Washington University of St. Louis
St Louis, Missouri, 63110, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
Wake Forest University Health Sciences
Wake Forest, North Carolina, 27157, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
LeBonheur Children's Hospital
Memphis, Tennessee, 38103, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Children's Memorial Hermann Hospital
Houston, Texas, 77030, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Primary Children's Hospital
Salt Lake City, Utah, 84112, United States
University of Washington Harborview
Seattle, Washington, 98195, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
Petersen EM, Fisher AD, April MD, Yazer MH, Braverman MA, Borgman MA, Schauer SG. The effect of the proportion of low-titer O whole blood for resuscitation in pediatric trauma patients on 6-, 12- and 24-hour survival. J Trauma Acute Care Surg. 2025 Apr 1;98(4):587-592. doi: 10.1097/TA.0000000000004564. Epub 2025 Feb 3.
PMID: 39898869DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philip C Spinella, MD
Univesrity of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The University of Pittsburgh Medical Center Investigational Research Pharmacy will provide each site the placebo and TXA. The research pharmacy at each site will draw the dose syringes. They will be blinded with a label indicating either drug A or B, and the pharmacy will log which patients received TXA or placebo, with all drugs labeled as investigational products.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Surgery and Critical Care Medicine
Study Record Dates
First Submitted
September 27, 2023
First Posted
October 6, 2023
Study Start
November 1, 2024
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
October 1, 2028
Last Updated
February 23, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Data will be shared 5 years after the trial has been published. The trial database will be shared to those who request the data and agree to collaborate with the principal investigators for the additional analyses.