Massive Transfusion in Children or MATIC-2 Trial
Phase: Recruiting
First Posted: November
Condition(s): Trauma Care
Other Study ID Number(s): MATIC-2
What Is the Purpose of This Study?
The purpose of the research study is to compare the effectiveness of two different treatments:
- Low titer group O whole blood (LTOWB) versus Component Therapy (CT), and
- Tranexamic Acid (TXA) versus saline fluid as a possible treatment for severe bleeding in injured children.
Who Can Take Part in This Study?
Inclusion criteria:
- Children, defined as less than 18 years old with traumatic injury
- Massive Transfusion Protocol activation AND confirmed or suspected life-threatening bleeding with low blood pressure for age (<5 percentile), a fast heart rate for age (>95th percentile), or a traumatic injury with exam findings consistent with severe bleeding (e.g., penetrating injury, blood collection in the chest cavity, swollen abdomen with bruising, amputation of limb).
For more study details, visit https://www.matic2.org
What Will Happen During This Study?
- As part of treatment for the study you received a combination of Tranexamic Acid (a medication used to help form blood clots) or saline fluid and low titer group O whole blood (blood as it flows in the body) or Component Therapy (a combination of separate red blood cells, platelets and plasma).
- Medical record review – We would like to continue to collect information from your medical records related to your demographics, medical history/physical exams, vital signs, laboratory and/or radiological results, treatments and other clinical information. This information will be used to better understand how the method used for transfusion will impact recovery.
- As part of this research study, you will be followed by the study staff for 28 days from hospital admission or until you leave the hospital. If you consent for continued participation, permitting the continued collection of your child’s medical records is a required part of participation.
- Blood draws at hours 0, 6 and 24 after transfusion and leftover clinical samples – Blood draws will be performed at the same time as routine standard of care clinical labs when possible. Blood will be collected by nurses who have experience and training in the procedure. The amount of blood to be collected at each draw will be roughly 18 mL (around 1 tablespoon).
Will We Be Paid for This Study?
No, you will not be compensated for your time.
Can I Opt Out of This Study?
Yes, you can alert the research staff if you want to discontinue participation after enrollment or email the study team to request an opt-out bracelet. Individuals with an opt-out bracelet will be treated according to the hospital’s standard of care for transfusions.