A Phase 3 interventional study of Low Titer Group O Whole Blood (LTOWB) and Placebo in Hemorrhagic Shock and Trauma Injury, sponsored by Philip Spinella. Recruiting at 23 sites in United States. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Philip Spinella · Phase 3, Interventional, and Treatment
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.
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:
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:
Mechanistic Objectives are to:
Pharmacokinetic objectives are to evaluate the PK and PD properties of TXA in a population of children with life-threatening traumatic bleeding.
79 studies on the registry are indexed under Shock, Hemorrhagic; 15 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 107 across 42 interventional studies indexed under Shock, Hemorrhagic.
Browse Shock, Hemorrhagic studies →Philip Spinella is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
General Inclusion Criteria:
AND
Confirmed or suspected active life-threatening traumatic bleeding with at least 2 of 3 of the following criteria:
General Exclusion Criteria:
Exclusion Criteria for the TXA/Placebo Domain
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Concurrent administration of LTOWB and TXA
Biological: Low Titer Group O Whole Blood (LTOWB) · Drug: Tranexamic Acid (TXA)
Concurrent administration of LTOWB and Placebo
Biological: Low Titer Group O Whole Blood (LTOWB) · Drug: Placebo
Concurrent administration of CT and TXA
Drug: Tranexamic Acid (TXA) · Biological: Component Therapy (CT)
Concurrent administration of CT and Placebo
Drug: Placebo · Biological: Component Therapy (CT)
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).
Component Therapy (CT) will be RBCs, plasma and platelet units in a 1:1:1 unit ratio. This will be given with Placebo
24 hours all cause mortality
Time frame: 24 hours
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.
Time frame: 6, 72 hours and 28 days
24 hours total blood product transfusion volumes
Total blood product transfusion in 24 hours after enrollment.
Time frame: 24 hours
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Tranexamic Acid
Philip Spinella