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New treatment option for Hemorrhagic Shock
Official title Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children
ClinicalTrials.gov ID: NCT06070350
What this study is testing
What is Low Titer Group O Whole Blood (LTOWB)?
Low Titer Group O Whole Blood (LTOWB) is an investigational medicine, being studied as a potential treatment for hemorrhagic shock.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The MATIC-2 is a multicenter clinical trial enrolling children who are less than 18 years of age with hemorrhagic shock potentially needing significant blood transfusion. The primary objective of the clinical trial is to determine the effectiveness of Low Titer Group O Whole Blood (LTOWB) compared to component therapy (CT), and Tranexamic Acid (TXA) compared to placebo in decreasing 24-hour all-cause mortality in children with traumatic life threatening hemorrhage.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 17
You may be able to join if
- General
- Children, defined as less than estimated18 years of age with traumatic injury
- MTP activation for confirmed or suspected active life-threatening traumatic bleeding AND Confirmed or suspected active life-threatening traumatic...
- Hypotension for age (\< 5% tile)
- Tachycardia for age (\>95th % tile)
You likely can't join if
- Patient with devastating traumatic brain injury not expected to survive due to magnitude of injury (example: Transhemispheric gunshot wound with...
- MTP activated but no blood products given
- Patients who required an ED thoracotomy or received more than 5 consecutive minutes of cardiopulmonary resuscitation (prior to receiving assigned by...
- Patients who are known or suspected to be pregnant on clinical examination
- Known prisoners as defined in protocol
- Known ward of the state
See the full eligibility criteria
- General
- Children, defined as less than estimated18 years of age with traumatic injury
- 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:
- Hypotension for age (\< 5% tile)
- Tachycardia for age (\>95th % tile)
- Traumatic injury with exam findings consistent with severe bleeding (e.g., penetrating injury, hemothorax, distended abdomen with bruising, amputation of limb). General
- 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)
- MTP activated but no blood products given
- Patients who required an ED thoracotomy or received more than 5 consecutive minutes of cardiopulmonary resuscitation (prior to receiving assigned by chance blood products)
- Patients who are known or suspected to be pregnant on clinical examination
- Known prisoners as defined in protocol
- Known ward of the state
- Isolated hanging, drowning or burns
- Previous enrollment in MATIC-2
- Prior study opt-out with bracelet Exclusion Criteria for the TXA/Placebo Domain
- Prehospital or pre-enrollment use of TXA
- Greater than 3 hours since time of injury
- History of seizure after the injury event
- Known allergy or hypersensitivity reaction to TXA
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Sacramento, California, United States
- Washington D.C., District of Columbia, United States
- Atlanta, Georgia, United States
- New Orleans, Louisiana, United States
- Jackson, Mississippi, United States
- St Louis, Missouri, United States
- Albuquerque, New Mexico, United States
- Wake Forest, North Carolina, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Pittsburgh, Pennsylvania, United States
- Memphis, Tennessee, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Salt Lake City, Utah, United States
- Seattle, Washington, United States
+ 1 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Little Rock, Arkansas, United States; Sacramento, California, United States; Washington D.C., District of Columbia, United States; Atlanta, Georgia, United States; New Orleans, Louisiana, United States and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.