Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-05 @ 1:13 AM
Study NCT ID:
NCT06070350
Status:
RECRUITING
Last Update Posted:
2025-03-28
First Post:
2023-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012771', 'term': 'Shock, Hemorrhagic'}, {'id': 'D000081084', 'term': 'Accidental Injuries'}], 'ancestors': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The University of Pittsburgh Medical Center Investigational Research Pharmacy will provide each site the placebo and TXA. The research pharmacy at each site will draw the dose syringes. They will be blinded with a label indicating either drug A or B, and the pharmacy will log which patients received TXA or placebo, with all drugs labeled as investigational products.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'MATIC-2 is a Bayesian, randomized, multicenter, adaptive platform phase III trial to examine the effectiveness and safety of LTOWB versus CT and TXA vs placebo in 1000 children at minimum 20 US high volume academic pediatric trauma centers. Mechanisms of Trauma induced Coagulopathy (TIC) and resuscitation effects will also be investigated. The trial will stratify pediatric trauma centers based on their reported Massive Transfusion Protocol (MTP) volume and then randomize them into four treatment combinations. After an initial enrollment phase, treatment sites will cross over to ensure that all treatments are tested across every site, eliminating biases by the time of the first interim analysis.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2023-09-27', 'studyFirstSubmitQcDate': '2023-09-29', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '24 hours all cause mortality', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': '6-hour, 72-hour and 28-day survival', 'timeFrame': '6, 72 hours and 28 days', 'description': 'Cumulative survival over time through 28 days post-enrollment: includes 6-hour, 72-hour and 28-day survival.'}, {'measure': '24 hours total blood product transfusion volumes', 'timeFrame': '24 hours', 'description': 'Total blood product transfusion in 24 hours after enrollment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Children', 'Pediatrics', 'Transfusion'], 'conditions': ['Hemorrhagic Shock', 'Trauma Injury']}, 'referencesModule': {'references': [{'pmid': '39898869', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "The MATIC-2 trial is a Bayesian, randomized, multicenter, adaptive platform phase III trial. The trial will include injured children with hemorrhagic shock anticipated to require massive blood transfusion, who will be randomized to receive either LTOWB or CT and Tranexamic Acid or placebo.\n\nThe 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.\n\nThe 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.\n\nObjectives:\n\nThe primary objectives are to:\n\n1. Determine the effectiveness of LTOWB to reduce all-cause 24-hour mortality compared to CT in children with traumatic life-threatening hemorrhage.\n2. Determine the effectiveness of TXA to reduce all-cause 24-hour mortality compared to placebo in children with traumatic life-threatening hemorrhage.\n\nSecondary 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.\n\nSafety objectives are to determine the effect of LTOWB and TXA on safety related outcomes/endpoints. The safety outcomes include:\n\n1. Acute kidney injury\n2. Acute respiratory distress syndrome\n3. Arrhythmia\n4. Abdominal compartment syndrome\n5. Bleeding after hemostasis requiring intervention\n6. Myocardial infarction\n7. Pneumonia\n8. Sepsis\n9. Stroke\n10. Seizure\n11. Thrombotic events (arterial or venous)\n12. Urinary Tract Infection\n13. Alloimmunization in Rh negative female recipients of Rh+ LTOWB or RBC's\n14. Organ failure (as determined by PELOD-2 score)\n\nMechanistic Objectives are to:\n\n1. Define trauma induced coagulopathy (TIC) according to measures of shock, hemostasis, and endothelial and immune function.\n2. 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.\n3. To determine the mechanisms of how hemostatic resuscitation therapies or combinations of therapies (LTOWB, CT, LTOWB + TXA, CT+TXA) improve TIC endotypes and outcomes.\n\nPharmacokinetic objectives are to evaluate the PK and PD properties of TXA in a population of children with life-threatening traumatic bleeding."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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 (\\< 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/Placebo 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'}, 'identificationModule': {'nctId': 'NCT06070350', 'acronym': 'MATIC-2', 'briefTitle': 'Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Massive Transfusion in Children: a Platform RCT of Whole Blood Compared to Component Therapy and Tranexamic Acid to Placebo in Life-threatening Traumatic Bleeding', 'orgStudyIdInfo': {'id': 'MATIC-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group 1 (LTOWB+TXA)', 'description': 'Concurrent administration of LTOWB and TXA', 'interventionNames': ['Biological: Low Titer Group O Whole Blood (LTOWB)', 'Drug: Tranexamic Acid (TXA)']}, {'type': 'OTHER', 'label': 'Group 2 (LTOWB+Placebo)', 'description': 'Concurrent administration of LTOWB and Placebo', 'interventionNames': ['Biological: Low Titer Group O Whole Blood (LTOWB)', 'Drug: Placebo']}, {'type': 'OTHER', 'label': 'Group 3 (CT+TXA)', 'description': 'Concurrent administration of CT and TXA', 'interventionNames': ['Drug: Tranexamic Acid (TXA)', 'Biological: Component Therapy (CT)']}, {'type': 'OTHER', 'label': 'Group 4 (CT+Placebo)', 'description': 'Concurrent administration of CT and Placebo', 'interventionNames': ['Drug: Placebo', 'Biological: Component Therapy (CT)']}], 'interventions': [{'name': 'Low Titer Group O Whole Blood (LTOWB)', 'type': 'BIOLOGICAL', 'description': '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.', 'armGroupLabels': ['Group 1 (LTOWB+TXA)', 'Group 2 (LTOWB+Placebo)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be provided to the research pharmacy at each of the clinical sites', 'armGroupLabels': ['Group 2 (LTOWB+Placebo)', 'Group 4 (CT+Placebo)']}, {'name': 'Tranexamic Acid (TXA)', 'type': 'DRUG', 'description': "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).", 'armGroupLabels': ['Group 1 (LTOWB+TXA)', 'Group 3 (CT+TXA)']}, {'name': 'Component Therapy (CT)', 'type': 'BIOLOGICAL', 'description': 'Component Therapy (CT) will be RBCs, plasma and platelet units in a 1:1:1 unit ratio. This will be given with Placebo', 'armGroupLabels': ['Group 3 (CT+TXA)', 'Group 4 (CT+Placebo)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84719', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Louis Magnotti, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maxson', 'role': 'CONTACT'}, {'name': 'Todd Maxson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Arkansas Children's Hospital", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daniel Nishijima, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Randall Burd, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's National Hospital", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ruth Hwu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Emory University-Arthur M. Blank Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarah Lazarus, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Emory University-Scottish Rite Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '70118', 'city': 'New Orleans', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kevin Harrell, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tulane School of Medicine', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew Kutcher, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lindsay Clukies, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Washington University of St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarah Moore, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '27157', 'city': 'Wake Forest', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lucas Neff, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 35.97987, 'lon': -78.50972}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julie Leonard, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Trisha Wong, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ward Richardson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital of Pittsburgh of UPMC", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '38103', 'city': 'Memphis', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Regan Williams, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "LeBonheur Children's Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Harold Lovvorn, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Barbara Gaines, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Adam Vogel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Charles Cox, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Memorial Hermann Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Susannah Nicholson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katie Russell, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Primary Children's Hospital", 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bryce Robinson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Washington Harborview', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': "Katherine Flynn-O'Brien, MD", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'centralContacts': [{'name': 'Jane Luce', 'role': 'CONTACT', 'email': 'jane.luce@pitt.edu', 'phone': '412-383-7853'}], 'overallOfficials': [{'name': 'Philip C Spinella, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univesrity of Pittsburgh'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'Data will be shared 5 years after the trial has been published. The trial database will be shared to those who request the data and agree to collaborate with the principal investigators for the additional analyses.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philip Spinella', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biomedical Advanced Research and Development Authority', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery and Critical Care Medicine', 'investigatorFullName': 'Philip Spinella', 'investigatorAffiliation': 'University of Pittsburgh'}}}}