Massive Transfusion in Children-2 (MATIC-2)
Bleeding is the most common cause of preventable death after injury in children. There have been no large studies to guide doctors in how best to care for children with life-threatening bleeding after trauma.
We are taking part in a national study to see what combination of treatments given soon after arrival in the emergency department can improve survival. The treatments include blood products (whole blood, red blood cells, plasma and platelets) and a medication that can help blood clot (tranexamic acid).
Research is normally only conducted with the express permission of the patient or patient’s legal guardian. However, it is often not possible to obtain consent to study treatments that are administered in life-threatening emergencies. The MATIC-2 trial will therefore be conducted under federal regulations that allow for an exception from informed consent (EFIC) (see study links for more information on this).
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.
Study phase: III
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
This study is enrolling patients who meet the following criteria
- Age under 18 years
- Traumatic injury with major bleeding and activation of massive transfusion protocol
Primary disease category: Trauma & Emergency Medicine
This study is enrolling healthy volunteers.
Sponsor: Biomedical Advanced Research and Development Authority (BARDA)
Protocol number: PRO00071698
Projected enrollment dates: September 2024 to September 2027
Official study title: Massive Transfusion in Children-2 (MATIC-2)
ClinicalTrials.gov page:
http://www.clinicaltrials.gov/show/NCT06070350