NCT06070350

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Philip Spinella · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Hemorrhagic Shock
• Trauma Injury

Interventions

Type	Name	Description
BIOLOGICAL	Low Titer Group O Whole Blood (LTOWB)	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.
DRUG	Placebo	Placebo will be provided to the research pharmacy at each of the clinical sites
DRUG	Tranexamic Acid (TXA)	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).
BIOLOGICAL	Component Therapy (CT)	Component Therapy (CT) will be RBCs, plasma and platelet units in a 1:1:1 unit ratio. This will be given with Placebo

Timeline

• Start date: 2024-11-01
• Primary completion: 2028-06-01
• Completion: 2028-10-01
• First posted: 2023-10-06
• Last updated: 2026-02-23

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study