The No. 1 cause of death in children is trauma. There are an estimated 2,000 pediatric deaths from traumatic bleeding in the U.S. each year that are preventable with optimal care, yet there have been no large-scale clinical trials to guide the best way to treat children with life-threatening bleeding after traumatic injury.
Massive Transfusion in Children-2 (MATIC-2) is a study aiming to improve trauma care in children. To do so, children with serious injuries who need emergent care will get one or more treatments that include blood products (component therapy (CT) and low titer group O whole blood (LTOWB)), and medications (Tranexamic Acid (TXA) or salt water). These treatments are already being given to children across the United States, but doctors aren’t sure which bundle of treatments is best. Many studies look at adults, but we don’t always know how to best treat kids.
This study will be completed at about 20 different hospitals in the United States. These hospitals will be split into four groups based on the four possible treatment combinations. Each group will rotate through all different combinations of care. This design helps to control for differences between sites. Up to 1,000 children will be in the study.
MATIC-2 uses exception from informed consent. Children with traumatic injuries often need help right away, and it is important to not delay treatment. The investigators will talk to the community to consult with them about the study before it begins.