Trauma is the leading cause of death in children. There have been no large-scale clinical trials to guide the best way to resuscitate children with life-threatening bleeding from traumatic injury. The MATIC-2 Trial is being conducted so that doctors can know how best to treat children who are severely injured and bleeding.
There are several ways that doctors treat children in the US with severe bleeding. The purpose of this study is to determine which bundle of care is best for injured children. In the US, most blood that is donated is separated into blood components because it can be used to help more people that way. Therefore, many injured children receive blood components (red blood cells, plasma, platelets) instead of whole blood. While there is some evidence that whole blood might be better when treating injured children we do not currently know whether whole blood or blood components are more helpful to people who need large amounts of blood after injury. The results of this study may be used to determine whether more whole blood will be made available for use in injured children. Additionally, children in this trial may receive a drug called tranexamic acid (TXA) which helps stabilize clots that form to stop bleeding. Tranexamic acid is the standard of care for injured adults and is used for other causes of bleeding in children, and there is some evidence that suggests that tranexamic acid might also benefit children who are bleeding as a result of trauma. All of these treatments included in this study are used routinely in children with life-threatening bleeding from trauma.
Children in this study will have suffered a serious and potentially life-threatening injury, resulting in significant blood loss. Because blood transfusions and lifesaving care must begin very soon after injured children arrive at the hospital, it is not possible for guardians to provide consent in advance to enter a study. Doctors will therefore enroll children into the study without obtaining parental consent in advance and get consent for continued participation after the child is stable.
This study is being conducted in 20 sites across the US and will enroll 1,000 people.
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To complete the MATIC-2 Trial survey, click here.