[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521496":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":48,"centralContacts":53,"locations":59,"responsibleParty":354,"collaborators":358,"id":362,"slug":363,"hasResults":364,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":368,"eligibilityCriteria":369,"healthyVolunteers":364,"sex":370,"minAge":34,"maxAge":371,"enrollmentInfo":372,"targetDuration":34,"studyType":375,"phases":376,"briefSummary":378,"conditions":379,"keywords":382,"overallStatus":62,"whyStopped":34,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":395},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8,14,19,24],{"label":9,"type":6,"description":10,"interventionNames":11},"Group 1 (LTOWB+TXA)","Concurrent administration of LTOWB and TXA",[12,13],"Biological: Low Titer Group O Whole Blood (LTOWB)","Drug: Tranexamic Acid (TXA)",{"label":15,"type":6,"description":16,"interventionNames":17},"Group 2 (LTOWB+Placebo)","Concurrent administration of LTOWB and Placebo",[12,18],"Drug: Placebo",{"label":20,"type":6,"description":21,"interventionNames":22},"Group 3 (CT+TXA)","Concurrent administration of CT and TXA",[13,23],"Biological: Component Therapy (CT)",{"label":25,"type":6,"description":26,"interventionNames":27},"Group 4 (CT+Placebo)","Concurrent administration of CT and Placebo",[18,23],[29,35,40,44],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"BIOLOGICAL","Low Titer Group O Whole Blood (LTOWB)","LTOWB is whole blood from group O donors with low titer (\\\u003C200) 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.",[9,15],null,{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":34},"DRUG","Placebo","Placebo will be provided to the research pharmacy at each of the clinical sites",[15,25],{"type":36,"name":41,"description":42,"armGroupLabels":43,"otherNames":34},"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\u002Fkg IV or IO (maximum 2 grams).",[9,20],{"type":30,"name":45,"description":46,"armGroupLabels":47,"otherNames":34},"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",[20,25],[49],{"name":50,"affiliation":51,"role":52},"Philip C Spinella, MD","Univesrity of Pittsburgh","PRINCIPAL_INVESTIGATOR",[54],{"name":55,"role":56,"phone":57,"phoneExt":34,"email":58},"Jane Luce","CONTACT","412-383-7853","jane.luce@pitt.edu",[60,77,92,105,118,131,140,153,166,179,192,205,218,231,244,257,270,283,295,303,315,328,341],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"University of Arizona","RECRUITING","Tucson","Arizona","84719","United States","US",{"type":69,"coordinates":70},"Point",[71,72],-110.92648,32.22174,{"lat":72,"lon":71},[75],{"name":76,"role":52,"phone":34,"phoneExt":34,"email":34},"Louis Magnotti, MD",{"facility":78,"status":62,"city":79,"state":80,"zip":81,"country":66,"countryCode":67,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Arkansas Children's Hospital","Little Rock","Arkansas","72202",{"type":69,"coordinates":83},[84,85],-92.28959,34.74648,{"lat":85,"lon":84},[88,90],{"name":89,"role":56,"phone":34,"phoneExt":34,"email":34},"Maxson",{"name":91,"role":52,"phone":34,"phoneExt":34,"email":34},"Todd Maxson, MD",{"facility":93,"status":62,"city":94,"state":95,"zip":96,"country":66,"countryCode":67,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"University of California Davis","Sacramento","California","95817",{"type":69,"coordinates":98},[99,100],-121.4944,38.58157,{"lat":100,"lon":99},[103],{"name":104,"role":52,"phone":34,"phoneExt":34,"email":34},"Daniel Nishijima, MD",{"facility":106,"status":62,"city":107,"state":108,"zip":109,"country":66,"countryCode":67,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Children's National Hospital","Washington D.C.","District of Columbia","20010",{"type":69,"coordinates":111},[112,113],-77.03637,38.89511,{"lat":113,"lon":112},[116],{"name":117,"role":52,"phone":34,"phoneExt":34,"email":34},"Randall Burd, MD",{"facility":119,"status":62,"city":120,"state":121,"zip":122,"country":66,"countryCode":67,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Emory University-Arthur M. Blank Hospital","Atlanta","Georgia","30329",{"type":69,"coordinates":124},[125,126],-84.38798,33.749,{"lat":126,"lon":125},[129],{"name":130,"role":52,"phone":34,"phoneExt":34,"email":34},"Ruth Hwu, MD",{"facility":132,"status":62,"city":120,"state":121,"zip":133,"country":66,"countryCode":67,"cosmosGeoPoint":134,"geoPoint":136,"contacts":137},"Emory University-Scottish Rite Hospital","30342",{"type":69,"coordinates":135},[125,126],{"lat":126,"lon":125},[138],{"name":139,"role":52,"phone":34,"phoneExt":34,"email":34},"Sarah Lazarus, MD",{"facility":141,"status":62,"city":142,"state":143,"zip":144,"country":66,"countryCode":67,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Tulane School of Medicine","New Orleans","Louisiana","70118",{"type":69,"coordinates":146},[147,148],-90.07507,29.95465,{"lat":148,"lon":147},[151],{"name":152,"role":52,"phone":34,"phoneExt":34,"email":34},"Kevin Harrell, MD",{"facility":154,"status":62,"city":155,"state":156,"zip":157,"country":66,"countryCode":67,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"University of Mississippi Medical Center","Jackson","Mississippi","39216",{"type":69,"coordinates":159},[160,161],-90.18481,32.29876,{"lat":161,"lon":160},[164],{"name":165,"role":52,"phone":34,"phoneExt":34,"email":34},"Matthew Kutcher, MD",{"facility":167,"status":62,"city":168,"state":169,"zip":170,"country":66,"countryCode":67,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Washington University of St. Louis","St Louis","Missouri","63110",{"type":69,"coordinates":172},[173,174],-90.19789,38.62727,{"lat":174,"lon":173},[177],{"name":178,"role":52,"phone":34,"phoneExt":34,"email":34},"Lindsay Clukies, MD",{"facility":180,"status":62,"city":181,"state":182,"zip":183,"country":66,"countryCode":67,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"University of New Mexico","Albuquerque","New Mexico","87131",{"type":69,"coordinates":185},[186,187],-106.65114,35.08449,{"lat":187,"lon":186},[190],{"name":191,"role":52,"phone":34,"phoneExt":34,"email":34},"Sarah Moore, MD",{"facility":193,"status":62,"city":194,"state":195,"zip":196,"country":66,"countryCode":67,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"Wake Forest University Health Sciences","Wake Forest","North Carolina","27157",{"type":69,"coordinates":198},[199,200],-78.50972,35.97987,{"lat":200,"lon":199},[203],{"name":204,"role":52,"phone":34,"phoneExt":34,"email":34},"Lucas Neff, MD",{"facility":206,"status":62,"city":207,"state":208,"zip":209,"country":66,"countryCode":67,"cosmosGeoPoint":210,"geoPoint":214,"contacts":215},"Nationwide Children's Hospital","Columbus","Ohio","43205",{"type":69,"coordinates":211},[212,213],-82.99879,39.96118,{"lat":213,"lon":212},[216],{"name":217,"role":52,"phone":34,"phoneExt":34,"email":34},"Julie Leonard, MD",{"facility":219,"status":62,"city":220,"state":221,"zip":222,"country":66,"countryCode":67,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"Oregon Health and Science University","Portland","Oregon","97239",{"type":69,"coordinates":224},[225,226],-122.67621,45.52345,{"lat":226,"lon":225},[229],{"name":230,"role":52,"phone":34,"phoneExt":34,"email":34},"Trisha Wong, MD",{"facility":232,"status":62,"city":233,"state":234,"zip":235,"country":66,"countryCode":67,"cosmosGeoPoint":236,"geoPoint":240,"contacts":241},"Children's Hospital of Pittsburgh of UPMC","Pittsburgh","Pennsylvania","15224",{"type":69,"coordinates":237},[238,239],-79.99589,40.44062,{"lat":239,"lon":238},[242],{"name":243,"role":52,"phone":34,"phoneExt":34,"email":34},"Ward Richardson, MD",{"facility":245,"status":62,"city":246,"state":247,"zip":248,"country":66,"countryCode":67,"cosmosGeoPoint":249,"geoPoint":253,"contacts":254},"LeBonheur Children's Hospital","Memphis","Tennessee","38103",{"type":69,"coordinates":250},[251,252],-90.04898,35.14953,{"lat":252,"lon":251},[255],{"name":256,"role":52,"phone":34,"phoneExt":34,"email":34},"Regan Williams, MD",{"facility":258,"status":259,"city":260,"state":247,"zip":261,"country":66,"countryCode":67,"cosmosGeoPoint":262,"geoPoint":266,"contacts":267},"Vanderbilt University Medical Center","NOT_YET_RECRUITING","Nashville","37232",{"type":69,"coordinates":263},[264,265],-86.78444,36.16589,{"lat":265,"lon":264},[268],{"name":269,"role":52,"phone":34,"phoneExt":34,"email":34},"Harold Lovvorn, MD",{"facility":271,"status":62,"city":272,"state":273,"zip":274,"country":66,"countryCode":67,"cosmosGeoPoint":275,"geoPoint":279,"contacts":280},"The University of Texas Southwestern Medical Center","Dallas","Texas","75390",{"type":69,"coordinates":276},[277,278],-96.80667,32.78306,{"lat":278,"lon":277},[281],{"name":282,"role":52,"phone":34,"phoneExt":34,"email":34},"Barbara Gaines, MD",{"facility":284,"status":62,"city":285,"state":273,"zip":286,"country":66,"countryCode":67,"cosmosGeoPoint":287,"geoPoint":291,"contacts":292},"Baylor College of Medicine","Houston","77030",{"type":69,"coordinates":288},[289,290],-95.36327,29.76328,{"lat":290,"lon":289},[293],{"name":294,"role":52,"phone":34,"phoneExt":34,"email":34},"Adam Vogel, MD",{"facility":296,"status":62,"city":285,"state":273,"zip":286,"country":66,"countryCode":67,"cosmosGeoPoint":297,"geoPoint":299,"contacts":300},"Children's Memorial Hermann Hospital",{"type":69,"coordinates":298},[289,290],{"lat":290,"lon":289},[301],{"name":302,"role":52,"phone":34,"phoneExt":34,"email":34},"Charles Cox, MD",{"facility":304,"status":62,"city":305,"state":273,"zip":306,"country":66,"countryCode":67,"cosmosGeoPoint":307,"geoPoint":311,"contacts":312},"University of Texas Health Science Center at San Antonio","San Antonio","78229",{"type":69,"coordinates":308},[309,310],-98.49363,29.42412,{"lat":310,"lon":309},[313],{"name":314,"role":52,"phone":34,"phoneExt":34,"email":34},"Susannah Nicholson, MD",{"facility":316,"status":62,"city":317,"state":318,"zip":319,"country":66,"countryCode":67,"cosmosGeoPoint":320,"geoPoint":324,"contacts":325},"Primary Children's Hospital","Salt Lake City","Utah","84112",{"type":69,"coordinates":321},[322,323],-111.89105,40.76078,{"lat":323,"lon":322},[326],{"name":327,"role":52,"phone":34,"phoneExt":34,"email":34},"Katie Russell, MD",{"facility":329,"status":62,"city":330,"state":331,"zip":332,"country":66,"countryCode":67,"cosmosGeoPoint":333,"geoPoint":337,"contacts":338},"University of Washington Harborview","Seattle","Washington","98195",{"type":69,"coordinates":334},[335,336],-122.33207,47.60621,{"lat":336,"lon":335},[339],{"name":340,"role":52,"phone":34,"phoneExt":34,"email":34},"Bryce Robinson, MD",{"facility":342,"status":62,"city":343,"state":344,"zip":345,"country":66,"countryCode":67,"cosmosGeoPoint":346,"geoPoint":350,"contacts":351},"Medical College of Wisconsin","Milwaukee","Wisconsin","53226",{"type":69,"coordinates":347},[348,349],-87.90647,43.0389,{"lat":349,"lon":348},[352],{"name":353,"role":52,"phone":34,"phoneExt":34,"email":34},"Katherine Flynn-O'Brien, MD",{"type":355,"investigatorFullName":356,"investigatorTitle":357,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"SPONSOR_INVESTIGATOR","Philip Spinella","Professor of Surgery and Critical Care Medicine",[359],{"name":360,"class":361},"Biomedical Advanced Research and Development Authority","FED","100521496","phase-3-massive-transfusion-in-children-2-a-trial-examining-life-threatening-hemorrhage-in-children-100521496",false,"NCT06070350","Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children","Massive Transfusion in Children: a Platform RCT of Whole Blood Compared to Component Therapy and Tranexamic Acid to Placebo in Life-threatening Traumatic Bleeding","MATIC-2","General Inclusion Criteria:\n\n1. Children, defined as less than estimated18 years of age with traumatic injury\n2. MTP activation for confirmed or suspected active life-threatening traumatic bleeding\n\nAND\n\nConfirmed or suspected active life-threatening traumatic bleeding with at least 2 of 3 of the following criteria:\n\n1. Hypotension for age (\\\u003C 5% tile)\n2. Tachycardia for age (\\>95th % tile)\n3. Traumatic injury with exam findings consistent with severe bleeding (e.g., penetrating injury, hemothorax, distended abdomen with bruising, amputation of limb).\n\nGeneral Exclusion Criteria:\n\n1. 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)\n2. MTP activated but no blood products given\n3. Patients who required an ED thoracotomy or received more than 5 consecutive minutes of cardiopulmonary resuscitation (prior to receiving randomized blood products)\n4. Patients who are known or suspected to be pregnant on clinical examination\n5. Known prisoners as defined in protocol\n6. Known ward of the state\n7. Isolated hanging, drowning or burns\n8. Previous enrollment in MATIC-2\n9. Prior study opt-out with bracelet\n\nExclusion Criteria for the TXA\u002FPlacebo Domain\n\n1. Prehospital or pre-enrollment use of TXA\n2. Greater than 3 hours since time of injury\n3. History of seizure after the injury event\n4. Known allergy or hypersensitivity reaction to TXA","ALL","17 Years",{"count":373,"type":374},1000,"ESTIMATED","INTERVENTIONAL",[377],"PHASE3","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.\n\nThe 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.",[380,381],"Hemorrhagic Shock","Trauma Injury",[383,384,385],"Children","Pediatrics","Transfusion","2026-05-07",{"date":388,"type":389},"2026-05-11","ACTUAL",{"date":391,"type":389},"2024-11-01",{"date":393,"type":374},"2028-10-01",{"name":356,"class":6},23]