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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Philip Spinella
Study ID
NCT06070350
Phase
PHASE3
Status
Recruiting
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Conditions

  • Hemorrhagic Shock
  • Trauma Injury

Eligibility Criteria

Sex
ALL
Age
N/A - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Low Titer Group O Whole Blood (LTOWB) — BIOLOGICAL
    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 — DRUG
    Placebo will be provided to the research pharmacy at each of the clinical sites
  • Tranexamic Acid (TXA) — DRUG
    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) — BIOLOGICAL
    Component Therapy (CT) will be RBCs, plasma and platelet units in a 1:1:1 unit ratio. This will be given with Placebo

Study Details

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.

Key Dates

Start date
Nov 1, 2024
Status verified
May 2026
Primary completion
Jun 1, 2028
Completion
Oct 1, 2028

Study Design

Enrollment
1,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Other: Group 1 (LTOWB+TXA)
    Concurrent administration of LTOWB and TXA
  • Other: Group 2 (LTOWB+Placebo)
    Concurrent administration of LTOWB and Placebo
  • Other: Group 3 (CT+TXA)
    Concurrent administration of CT and TXA
  • Other: Group 4 (CT+Placebo)
    Concurrent administration of CT and Placebo

Primary Outcome Measure

24 hours all cause mortality [ Time Frame: 24 hours ]

Central Contacts

Locations (23)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona84719
Louis Magnotti, MD (PRINCIPAL_INVESTIGATOR)
Arkansas Children's HospitalLittle RockArkansas72202
Maxson
Todd Maxson, MD (PRINCIPAL_INVESTIGATOR)
University of California DavisSacramentoCalifornia95817
Daniel Nishijima, MD (PRINCIPAL_INVESTIGATOR)
Children's National HospitalWashington D.C.District of Columbia20010
Randall Burd, MD (PRINCIPAL_INVESTIGATOR)
Emory University-Arthur M. Blank HospitalAtlantaGeorgia30329
Ruth Hwu, MD (PRINCIPAL_INVESTIGATOR)
Emory University-Scottish Rite HospitalAtlantaGeorgia30342
Sarah Lazarus, MD (PRINCIPAL_INVESTIGATOR)
Tulane School of MedicineNew OrleansLouisiana70118
Kevin Harrell, MD (PRINCIPAL_INVESTIGATOR)
University of Mississippi Medical CenterJacksonMississippi39216
Matthew Kutcher, MD (PRINCIPAL_INVESTIGATOR)
Washington University of St. LouisSt LouisMissouri63110
Lindsay Clukies, MD (PRINCIPAL_INVESTIGATOR)
University of New MexicoAlbuquerqueNew Mexico87131
Sarah Moore, MD (PRINCIPAL_INVESTIGATOR)
Wake Forest University Health SciencesWake ForestNorth Carolina27157
Lucas Neff, MD (PRINCIPAL_INVESTIGATOR)
Nationwide Children's HospitalColumbusOhio43205
Julie Leonard, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health and Science UniversityPortlandOregon97239
Trisha Wong, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of Pittsburgh of UPMCPittsburghPennsylvania15224
Ward Richardson, MD (PRINCIPAL_INVESTIGATOR)
LeBonheur Children's HospitalMemphisTennessee38103
Regan Williams, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
Harold Lovvorn, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas Southwestern Medical CenterDallasTexas75390
Barbara Gaines, MD (PRINCIPAL_INVESTIGATOR)
Baylor College of MedicineHoustonTexas77030
Adam Vogel, MD (PRINCIPAL_INVESTIGATOR)
Children's Memorial Hermann HospitalHoustonTexas77030
Charles Cox, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Health Science Center at San AntonioSan AntonioTexas78229
Susannah Nicholson, MD (PRINCIPAL_INVESTIGATOR)
Primary Children's HospitalSalt Lake CityUtah84112
Katie Russell, MD (PRINCIPAL_INVESTIGATOR)
University of Washington HarborviewSeattleWashington98195
Bryce Robinson, MD (PRINCIPAL_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53226
Katherine Flynn-O'Brien, MD (PRINCIPAL_INVESTIGATOR)

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University of Arizona· Tucson, AZArkansas Children's Hospital· Little Rock, ARUniversity of California Davis· Sacramento, CAChildren's National Hospital· Washington D.C., DCEmory University-Arthur M. Blank Hospital· Atlanta, GAEmory University-Scottish Rite Hospital· Atlanta, GA

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