Co-PIs: Philip C. Spinella, Christine M. Leeper, Stephen Wisniewski, and Abdus S. Wahed

Title: Massive Transfusion in Children-II (MATIC-II)

Description: Trauma is the leading cause of death in children, with firearm-related injury and motor vehicle crashes as the top two sources of injury. In the U.S., an estimated 2,000 pediatric deaths caused by bleeding-related trauma are preventable with timely and effective care every year. During a mass casualty incident, such as a radiological or nuclear incident, children are likely to suffer from hemopoietic radiation injury as well as blunt, penetrating, and blast injuries that will cause significant blood loss that necessitate blood transfusions. Although children’s coagulation and physiologic response to bleeding differs from adults, pediatric trauma resuscitation practice guidelines are derived from adult data due to a lack of high-quality research in children. Survival outcomes are also worse in children with life-threatening traumatic injury compared to adults. This highlights the need to determine optimal transfusion practices in pediatric populations.

The trial will examine the safety and effectiveness of transfusion with whole blood versus component therapy (CT), as well as tranexamic acid (TXA), a drug that helps prevent bleeding, vs. placebo. The current standard of care for blood transfusions is to transfuse red blood cells, frozen plasma, and platelet concentrates separately in a balanced proportion to address specific deficiencies and clotting abnormalities. Whole blood is unseparated and contains all the component products in one bag.

In children with life-threatening hemorrhage from trauma, whole blood transfusion compared to CT may improve patient outcomes by decreasing the total blood transfused, improving oxygen delivery and hemostasis (stopping the flow of blood from an injury), and increasing survival. This clinical trial will also examine TXA, which may reduce the volume of blood needed for transfusion and improve survival in injured children. No prospective multicenter trials compare whole blood to CT or TXA to placebo in pediatric trauma patients, therefore this study may address a critical gap in care.

This effort aligns with BARDA’s overarching strategy, outlined in the 2022-2026 Strategic Plan, to protect all members of our communities against an evolving threat landscape. This includes supporting development of MCMs to address critical gaps in the treatment of children.

Source: Biomedical Advanced Research and Development Authority

Amount: $34 million