Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children
NCT ID: NCT06070350
Last Updated: 2025-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1000 participants
INTERVENTIONAL
2024-11-01
2028-10-01
Brief Summary
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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.
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Detailed Description
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The study investigators hypothesize that the use of LTOWB is non-inferior and/or superior for 24-hour mortality and that LTOWB does not increase the risk of adverse events or outcomes, such as thrombotic events, compared to CT.
The investigators also hypothesize that the use of TXA is superior for 24-hour mortality and does not increase the risk of adverse events or outcomes, such as thrombotic events, compared to placebo.
Objectives:
The primary objectives are to:
1. Determine the effectiveness of LTOWB to reduce all-cause 24-hour mortality compared to CT in children with traumatic life-threatening hemorrhage.
2. Determine the effectiveness of TXA to reduce all-cause 24-hour mortality compared to placebo in children with traumatic life-threatening hemorrhage.
Secondary objectives are to determine the effectiveness and safety of LTOWB and TXA to improve secondary and exploratory outcomes (or endpoints) in children with traumatic life-threatening hemorrhage.
Safety objectives are to determine the effect of LTOWB and TXA on safety related outcomes/endpoints. The safety outcomes include:
1. Acute kidney injury
2. Acute respiratory distress syndrome
3. Arrhythmia
4. Abdominal compartment syndrome
5. Bleeding after hemostasis requiring intervention
6. Myocardial infarction
7. Pneumonia
8. Sepsis
9. Stroke
10. Seizure
11. Thrombotic events (arterial or venous)
12. Urinary Tract Infection
13. Alloimmunization in Rh negative female recipients of Rh+ LTOWB or RBC's
14. Organ failure (as determined by PELOD-2 score)
Mechanistic Objectives are to:
1. Define trauma induced coagulopathy (TIC) according to measures of shock, hemostasis, and endothelial and immune function.
2. To determine if measures of shock, endothelial, immune, and hemostasis function upon admission (TIC endotype) predicts which hemostatic resuscitation therapies or combinations of therapies (LTOWB, CT, LTOWB + TXA, CT+TXA) for each study group improves outcomes without increasing the risk of adverse events.
3. To determine the mechanisms of how hemostatic resuscitation therapies or combinations of therapies (LTOWB, CT, LTOWB + TXA, CT+TXA) improve TIC endotypes and outcomes.
Pharmacokinetic objectives are to evaluate the PK and PD properties of TXA in a population of children with life-threatening traumatic bleeding.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Group 1 (LTOWB+TXA)
Concurrent administration of LTOWB and TXA
Low Titer Group O Whole Blood (LTOWB)
LTOWB is whole blood from group O donors with low titer (\<200) anti-A and anti-B antibodies. Up to 8 units of LTOWB will be allowed unless local clinical practice allows for a higher maximum dose.
Tranexamic Acid (TXA)
TXA is a synthetic lysine analog that competitively inhibit activation of plasminogen, thereby decreasing the conversion of plasminogen to plasmin, preventing degradation of fibrin's matrix structure. Dose is 25mg/kg IV or IO (maximum 2 grams).
Group 2 (LTOWB+Placebo)
Concurrent administration of LTOWB and Placebo
Low Titer Group O Whole Blood (LTOWB)
LTOWB is whole blood from group O donors with low titer (\<200) anti-A and anti-B antibodies. Up to 8 units of LTOWB will be allowed unless local clinical practice allows for a higher maximum dose.
Placebo
Placebo will be provided to the research pharmacy at each of the clinical sites
Group 3 (CT+TXA)
Concurrent administration of CT and TXA
Tranexamic Acid (TXA)
TXA is a synthetic lysine analog that competitively inhibit activation of plasminogen, thereby decreasing the conversion of plasminogen to plasmin, preventing degradation of fibrin's matrix structure. Dose is 25mg/kg IV or IO (maximum 2 grams).
Component Therapy (CT)
Component Therapy (CT) will be RBCs, plasma and platelet units in a 1:1:1 unit ratio. This will be given with Placebo
Group 4 (CT+Placebo)
Concurrent administration of CT and Placebo
Placebo
Placebo will be provided to the research pharmacy at each of the clinical sites
Component Therapy (CT)
Component Therapy (CT) will be RBCs, plasma and platelet units in a 1:1:1 unit ratio. This will be given with Placebo
Interventions
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Low Titer Group O Whole Blood (LTOWB)
LTOWB is whole blood from group O donors with low titer (\<200) anti-A and anti-B antibodies. Up to 8 units of LTOWB will be allowed unless local clinical practice allows for a higher maximum dose.
Placebo
Placebo will be provided to the research pharmacy at each of the clinical sites
Tranexamic Acid (TXA)
TXA is a synthetic lysine analog that competitively inhibit activation of plasminogen, thereby decreasing the conversion of plasminogen to plasmin, preventing degradation of fibrin's matrix structure. Dose is 25mg/kg IV or IO (maximum 2 grams).
Component Therapy (CT)
Component Therapy (CT) will be RBCs, plasma and platelet units in a 1:1:1 unit ratio. This will be given with Placebo
Eligibility Criteria
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Inclusion Criteria
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).
Exclusion Criteria
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
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
17 Years
ALL
No
Sponsors
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Biomedical Advanced Research and Development Authority
FED
Philip Spinella
OTHER
Responsible Party
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Philip Spinella
Professor of Surgery and Critical Care Medicine
Principal Investigators
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Philip C Spinella, MD
Role: PRINCIPAL_INVESTIGATOR
Univesrity of Pittsburgh
Locations
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University of Arizona
Tucson, Arizona, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
University of California Davis
Sacramento, California, United States
Children's National Hospital
Washington D.C., District of Columbia, United States
Emory University-Arthur M. Blank Hospital
Atlanta, Georgia, United States
Emory University-Scottish Rite Hospital
Atlanta, Georgia, United States
Tulane School of Medicine
New Orleans, Louisiana, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Washington University of St. Louis
St Louis, Missouri, United States
University of New Mexico
Albuquerque, New Mexico, United States
Wake Forest University Health Sciences
Wake Forest, North Carolina, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
LeBonheur Children's Hospital
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Children's Memorial Hermann Hospital
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
University of Washington Harborview
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Maxson
Role: primary
References
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Petersen EM, Fisher AD, April MD, Yazer MH, Braverman MA, Borgman MA, Schauer SG. The effect of the proportion of low-titer O whole blood for resuscitation in pediatric trauma patients on 6-, 12- and 24-hour survival. J Trauma Acute Care Surg. 2025 Apr 1;98(4):587-592. doi: 10.1097/TA.0000000000004564. Epub 2025 Feb 3.
Other Identifiers
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MATIC-002
Identifier Type: -
Identifier Source: org_study_id
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