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Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children

RecruitingPhase 3

Massive Transfusion in Children: a Platform RCT of Whole Blood Compared to Component Therapy and Tranexamic Acid to Placebo in Life-threatening Traumatic Bleeding

Who can join

Up to age 17 · All sexes

Full eligibility 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

About the study

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.

What is being tested

Sponsor: Philip Spinella · Participants: 1,000 · Started: Nov 1, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06070350

Locations in the U.S.

ArizonaUniversity of Arizona, Tucson
ArkansasArkansas Children's Hospital, Little Rock
CaliforniaUniversity of California Davis, Sacramento
District of ColumbiaChildren's National Hospital, Washington D.C.
GeorgiaEmory University-Arthur M. Blank Hospital, Atlanta
MississippiUniversity of Mississippi Medical Center, Jackson
MissouriWashington University of St. Louis, St Louis
New MexicoUniversity of New Mexico, Albuquerque
North CarolinaWake Forest University Health Sciences, Wake Forest
OhioNationwide Children's Hospital, Columbus
OregonOregon Health and Science University, Portland
PennsylvaniaChildren's Hospital of Pittsburgh of UPMC, Pittsburgh
TennesseeLeBonheur Children's Hospital, Memphis
Vanderbilt University Medical Center, Nashville (Not yet recruiting)
TexasBaylor College of Medicine, Houston
Children's Memorial Hermann Hospital, Houston
University of Texas Health Science Center at San Antonio, San Antonio
UtahPrimary Children's Hospital, Salt Lake City
WashingtonUniversity of Washington Harborview, Seattle
WisconsinMedical College of Wisconsin, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.