MATIC-2Massive Transfusion in Children: a Platform RCT of Whole Blood Compared to Component Therapy and Tranexamic Acid to Placebo in Life-threatening Traumatic Bleeding
Low Titer Group O Whole Blood (LTOWB)
+ Tranexamic Acid (TXA)
+ Placebo
Accidental Injuries+4
+ Hemorrhage
+ Pathologic Processes
Treatment Study
Summary
Study start date: November 1, 2024
Actual date on which the first participant was enrolled.The study is designed to help children who have suffered severe injuries and are experiencing life-threatening bleeding. It aims to compare two different blood transfusion methods: Low-Titer O Whole Blood (LTOWB) and Component Therapy (CT), and to evaluate the use of Tranexamic Acid (TXA) versus a placebo. The goal is to see which method and medication help improve survival rates within the first 24 hours without increasing the risk of complications such as blood clots. This research is important as it could lead to better treatment options and improved survival for children facing life-threatening bleeding situations. Participants in the study will be randomly assigned to receive either the LTOWB or CT, and either TXA or a placebo. These treatments will be administered to see their effectiveness in reducing mortality and preventing complications. The study will closely monitor for any adverse effects like kidney injury, respiratory issues, and infections, among others. Researchers will also look at how the body responds to these treatments by measuring different factors related to blood clotting and immune function. This comprehensive approach aims to identify the safest and most effective treatment for children with severe bleeding due to trauma.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1000 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Until 17 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
General Inclusion Criteria: 1. Children, defined as less than estimated18 years of age with traumatic injury 2. MTP activation for confirmed or suspected active life-threatening traumatic bleeding AND Confirmed or suspected active life-threatening traumatic bleeding with at least 2 of 3 of the following criteria: 1. Hypotension for age (\< 5% tile) 2. Tachycardia for age (\>95th % tile) 3. Traumatic injury with exam findings consistent with severe bleeding (e.g., penetrating injury, hemothorax, distended abdomen with bruising, amputation of limb). General Exclusion Criteria: 1. Patient with devastating traumatic brain injury not expected to survive due to magnitude of injury (example: Transhemispheric gunshot wound with signs of herniation, GCS score of 3 with fixed and dilated pupils) 2. MTP activated but no blood products given 3. Patients who required an ED thoracotomy or received more than 5 consecutive minutes of cardiopulmonary resuscitation (prior to receiving randomized blood products) 4. Patients who are known or suspected to be pregnant on clinical examination 5. Known prisoners as defined in protocol 6. Known ward of the state 7. Isolated hanging, drowning or burns 8. Previous enrollment in MATIC-2 9. Prior study opt-out with bracelet Exclusion Criteria for the TXA/Placebo Domain 1. Prehospital or pre-enrollment use of TXA 2. Greater than 3 hours since time of injury 3. History of seizure after the injury event 4. Known allergy or hypersensitivity reaction to TXA
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Group II
Group III
Group IV
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 23 locations
Arkansas Children's Hospital
Little Rock, United StatesUniversity of California Davis
Sacramento, United StatesChildren's National Hospital
Washington D.C., United States