Status and phase
Conditions
Treatments
About
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.
Full 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:
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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
Primary purpose
Allocation
Interventional model
Masking
1,000 participants in 4 patient groups
Loading...
Central trial contact
Jane Luce
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal