Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06070350 |
Other study ID # |
MATIC-002 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
Phase 3
|
First received |
|
Last updated |
|
Start date |
September 1, 2024 |
Est. completion date |
September 1, 2028 |
Study information
Verified date |
October 2023 |
Source |
University of Pittsburgh |
Contact |
Jane Luce |
Phone |
412-383-7853 |
Email |
jane.luce[@]pitt.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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 (CT), and Tranexamic Acid (TXA)
compared to placebo in decreasing 24-hour all-cause mortality in children with traumatic life
threatening hemorrhage.
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. Sepsis
4. Thromboembolism: arterial and venous
5. Markers of hemolysis
6. Alloimmunization in Rh negative female recipients of Rh+ LTOWB
7. Transfusion-related adverse events 8 Serious Adverse Events (SAEs)
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.