Children’s Medical Center Dallas seeks community participation in trauma research study to investigate treatment strategies for critically injured children
DALLAS – Sept. 23, 2024 – Bleeding is the most common cause of preventable death after injury. Researchers at Children’s Medical Center Dallas are seeking community consultation for possible future participation from parents and legal guardians in a study that will compare two resuscitation treatments (whole blood versus traditional blood component therapy, and tranexamic acid versus no tranexamic acid) for children ages 1 month to 18 years old. The goal is to compare which strategies can improve survival for pediatric patients who have suffered a severe injury.
The traditional approach for treating patients who are experiencing severe bleeding is to administer multiple separate units of red blood cells, plasma, and platelets – known as component therapy. However, recent evidence from military and civilian medicine suggests that survival may be better when patients receive whole blood, instead of previously separated blood products. Some centers also use tranexamic acid in addition to whole blood or blood components as a treatment for severe bleeding. It is not known which strategy works best for severely injured children.
“There is a growing body of evidence that tranexamic acid and/or whole blood may reduce the chance of dying in injured children who require blood products,” explained Barbara Gaines, M.D., Chief General Surgeon at Children’s Medical Center Dallas and Professor in the Department of Surgery at UT Southwestern Medical Center. The Massive Transfusion in Children-II, or MATIC-2 trial, will compare these resuscitation strategies, in addition to all standard care, in injured children with massive bleeding.
“The standard treatment of injured patients who are bleeding involves the transfusion of different types of blood products, as well as the use of medications to help the blood clot better, along with surgery to stop the bleeding,” said Dr. Gaines.
Patients in this study will have suffered a serious and potentially life-threatening injury, causing significant blood loss, and requiring immediate lifesaving interventions. These types of injuries are emergencies that occur unexpectedly, and it may not be possible for parents and guardians to provide consent for patients ahead of time.
If the community feedback is positive and an independent review board (IRB) approves the study, then Children’s Medical Center Dallas will participate in this trial. Community members who do not want to participate can request a bracelet for their child, indicating their choice to opt out. If feasible, doctors will obtain consent from parents and guardians of patients who fit the study criteria. If consent is not feasible, patients who fit the criteria will be automatically enrolled without their individual consent if they are not wearing an opt-out bracelet.
The MATIC-2 trial will be conducted in 20 leading trauma centers in the U.S. and will include 1,000 patients. The trial will begin between late 2024 and last until 2028 and is funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response, within the U.S. Department of Health and Human Services under contract number 75A50123C00047.
“The results of this study have the potential to change the way trauma patients are treated,” said Dr. Gaines. “If we can determine the best combination of treatments for trauma patients, we can continue to transform the standard of care and save thousands of lives.”
The study team members are asking for feedback from the Children’s Medical Center Dallas community about this study to help determine whether the community wants this area to participate in this study. Please consider visiting the website below to learn more about this study and to provide your feedback to the local physicians regarding emergency research. You can do this via phone call, email, or completing a brief anonymous survey. The link to the local website is Qualtrics Survey | Qualtrics Experience Management.
Additional information about the study and emergency research can be found at: