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Hemorrhagic ShockPhase 3MATIC-2NCT06070350

Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children

A Phase 3 study testing Low Titer Group O Whole Blood (LTOWB), Tranexamic Acid (TXA) and Component Therapy (CT) in people with Hemorrhagic Shock and Trauma Injury, run by Philip Spinella at 23 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages Up to 17 years
Conditions the study is for
Hemorrhagic Shock, Trauma Injury
What is being tested?
Low Titer Group O Whole Blood (LTOWB), Tranexamic Acid (TXA) and Component Therapy (CT)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,000 participants
Where
23 sitesUnited States
Study dates
1 Nov 2024to 1 Oct 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

None listed.

Who cannot join

  • 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

Trial locations and contacts

23 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Thomas Byers contact

412-383-2340

tdb33@pitt.edu

23 sites in 1 country

United States23 sites, 20 recruiting

  • University of New Mexico

    Albuquerque, New Mexico, 87131

    Sarah Moore, MD

    Recruiting

  • Emory University-Arthur M. Blank Hospital

    Atlanta, Georgia, 30329

    Ruth Hwu, MD

    Recruiting

  • Emory University-Scottish Rite Hospital

    Atlanta, Georgia, 30342

    Terminated

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

    Julie Leonard, MD

    Recruiting

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Terminated

  • Baylor College of Medicine

    Houston, Texas, 77030

    Adam Vogel, MD

    Recruiting

  • Children's Memorial Hermann Hospital

    Houston, Texas, 77030

    Charles Cox, MD

    Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

    Matthew Kutcher, MD

    Recruiting

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202

    Maxson

    Todd Maxson, MD

    Recruiting

  • LeBonheur Children's Hospital

    Memphis, Tennessee, 38103

    Regan Williams, MD

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Katherine Flynn-O'Brien, MD

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Harold Lovvorn, MD

    Not yet recruiting

  • Tulane School of Medicine

    New Orleans, Louisiana, 70118

    Withdrawn

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15224

    Ward Richardson, MD

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Trisha Wong, MD

    Recruiting

  • University of California Davis

    Sacramento, California, 95817

    Daniel Nishijima, MD

    Recruiting

  • Primary Children's Hospital

    Salt Lake City, Utah, 84112

    Katie Russell, MD

    Recruiting

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

    Susannah Nicholson, MD

    Recruiting

  • University of Washington Harborview

    Seattle, Washington, 98195

    Bryce Robinson, MD

    Recruiting

  • Washington University of St. Louis

    St Louis, Missouri, 63110

    Lindsay Clukies, MD

    Recruiting

  • University of Arizona

    Tucson, Arizona, 84719

    Louis Magnotti, MD

    Recruiting

  • Wake Forest University Health Sciences

    Wake Forest, North Carolina, 27157

    Lucas Neff, MD

    Recruiting

  • Children's National Hospital

    Washington D.C., District of Columbia, 20010

    Randall Burd, MD

    Recruiting

Other trials in United States

About this study

Official title: Massive Transfusion in Children: a Platform RCT of Whole Blood Compared to Component Therapy and Tranexamic Acid to Placebo in Life-threatening Traumatic Bleeding

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.

Read the detailed description

The MATIC-2 trial is a Bayesian, randomized, multicenter, adaptive platform phase III trial. The trial will include injured children with hemorrhagic shock anticipated to require massive blood transfusion, who will be randomized to receive either LTOWB or CT and Tranexamic Acid or placebo.

The study investigators hypothesize that the use of LTOWB is non-inferior and/or superior for 24-hour mortality and that LTOWB does not increase the risk of adverse events or outcomes, such as thrombotic events, compared to CT.

The investigators also hypothesize that the use of TXA is superior for 24-hour mortality and does not increase the risk of adverse events or outcomes, such as thrombotic events, compared to placebo.

Objectives:

The primary objectives are to:

  1. Determine the effectiveness of LTOWB to reduce all-cause 24-hour mortality compared to CT in children with traumatic life-threatening hemorrhage.
  2. Determine the effectiveness of TXA to reduce all-cause 24-hour mortality compared to placebo in children with traumatic life-threatening hemorrhage.

Secondary objectives are to determine the effectiveness and safety of LTOWB and TXA to improve secondary and exploratory outcomes (or endpoints) in children with traumatic life-threatening hemorrhage.

Safety objectives are to determine the effect of LTOWB and TXA on safety related outcomes/endpoints. The safety outcomes include:

  1. Acute kidney injury
  2. Acute respiratory distress syndrome
  3. Arrhythmia
  4. Abdominal compartment syndrome
  5. Bleeding after hemostasis requiring intervention
  6. Myocardial infarction
  7. Pneumonia
  8. Sepsis
  9. Stroke
  10. Seizure
  11. Thrombotic events (arterial or venous)
  12. Urinary Tract Infection
  13. Alloimmunization in Rh negative female recipients of Rh+ LTOWB or RBC's
  14. Organ failure (as determined by PELOD-2 score)

Mechanistic Objectives are to:

  1. Define trauma induced coagulopathy (TIC) according to measures of shock, hemostasis, and endothelial and immune function.
  2. To determine if measures of shock, endothelial, immune, and hemostasis function upon admission (TIC endotype) predicts which hemostatic resuscitation therapies or combinations of therapies (LTOWB, CT, LTOWB + TXA, CT+TXA) for each study group improves outcomes without increasing the risk of adverse events.
  3. To determine the mechanisms of how hemostatic resuscitation therapies or combinations of therapies (LTOWB, CT, LTOWB + TXA, CT+TXA) improve TIC endotypes and outcomes.

Pharmacokinetic objectives are to evaluate the PK and PD properties of TXA in a population of children with life-threatening traumatic bleeding.

Being tested
Low Titer Group O Whole Blood (LTOWB), Placebo, Tranexamic Acid (TXA), Component Therapy (CT)
Keywords
Children, Pediatrics, Transfusion
Medical subject headings
Shock, Hemorrhagic, Accidental Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low Titer Group O Whole Blood (LTOWB)Biological

    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.

  • PlaceboDrug

    Placebo will be provided to the research pharmacy at each of the clinical sites

  • Tranexamic Acid (TXA)Drug

    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).

  • Component Therapy (CT)Biological

    Component Therapy (CT) will be RBCs, plasma and platelet units in a 1:1:1 unit ratio. This will be given with Placebo

Study groups in NCT06070350
Study groupRoleWhat they receive
Group 1 (LTOWB+TXA)OtherConcurrent administration of LTOWB and TXA
Receives: Biological: Low Titer Group O Whole Blood (LTOWB); Drug: Tranexamic Acid (TXA)
Group 2 (LTOWB+Placebo)OtherConcurrent administration of LTOWB and Placebo
Receives: Biological: Low Titer Group O Whole Blood (LTOWB); Drug: Placebo
Group 3 (CT+TXA)OtherConcurrent administration of CT and TXA
Receives: Drug: Tranexamic Acid (TXA); Biological: Component Therapy (CT)
Group 4 (CT+Placebo)OtherConcurrent administration of CT and Placebo
Receives: Drug: Placebo; Biological: Component Therapy (CT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 24 hours all cause mortality

    Measured: 24 hours

Secondary outcomes (2)

  1. 6-hour, 72-hour and 28-day survival

    Cumulative survival over time through 28 days post-enrollment: includes 6-hour, 72-hour and 28-day survival.

    Measured: 6, 72 hours and 28 days

  2. 24 hours total blood product transfusion volumes

    Total blood product transfusion in 24 hours after enrollment.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2023
  2. Study start1 Nov 2024
  3. Primary completion1 Jun 2028 (estimated)
  4. Study completion1 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
MATIC-2 is a Bayesian, randomized, multicenter, adaptive platform phase III trial to examine the effectiveness and safety of LTOWB versus CT and TXA vs placebo in 1000 children at minimum 20 US high volume academic pediatric trauma centers. Mechanisms of Trauma induced Coagulopathy (TIC) and resuscitation effects will also be investigated. The trial will stratify pediatric trauma centers based on their reported Massive Transfusion Protocol (MTP) volume and then randomize them into four treatment combinations. After an initial enrollment phase, treatment sites will cross over to ensure that all treatments are tested across every site, eliminating biases by the time of the first interim analysis.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06070350
Sponsor's protocol ID
MATIC-2
Other IDs
75A50123C00047
Acronym
MATIC-2
Status last verified
Sep 2026
First submitted
27 Sep 2023
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 39898869

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Low Titer Group O Whole Blood (LTOWB), Tranexamic Acid (TXA) and Component Therapy (CT) in people with Hemorrhagic Shock and Trauma Injury, run by Philip Spinella at 23 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Thomas Byers (412-383-2340, tdb33@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

24 hours all cause mortality (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06070350, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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