[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100392231":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":34,"centralContacts":40,"locations":33,"responsibleParty":48,"collaborators":52,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":33,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":79,"overallStatus":86,"whyStopped":33,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":33},{"fullName":5,"class":6},"University of California, Davis","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Tranexamic acid 15 mg\u002Fkg bolus","EXPERIMENTAL","Subjects will receive a 15 mg\u002Fkg bolus of tranexamic acid over 30 minutes followed by a 2 mg\u002Fkg\u002Fh infusion over 8 hours. This represents 31 mg\u002Fkg total dose of TXA.",[13],"Drug: Tranexamic acid injection",{"label":15,"type":10,"description":16,"interventionNames":17},"Tranexamic acid 30 mg\u002Fkg bolus","Subjects will receive a 30 mg\u002Fkg bolus of tranexamic acid over 30 minutes followed by a 4 mg\u002Fkg\u002Fh infusion over 8 hours. This represents 62 mg\u002Fkg total dose of TXA.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Tranexamic acid 45 mg\u002Fkg bolus","Subjects will receive a 45 mg\u002Fkg bolus of tranexamic acid over 30 minutes followed by a 6 mg\u002Fkg\u002Fh infusion over 8 hours. This represents 91 mg\u002Fkg total dose of TXA. This dosing arm will only open if a dose-effect is determined based on accumulating data.",[13],{"label":23,"type":24,"description":25,"interventionNames":26},"Placebo","PLACEBO_COMPARATOR","Subjects in the placebo group will receive a bolus dose of normal saline over 10 minutes followed by a normal saline infusion over 8 hours",[13],[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Tranexamic acid injection","Active drug is provided to participants as described based on the TXA arm they are randomized to.",[23,9,15,19],null,[35,38],{"name":36,"affiliation":5,"role":37},"Daniel K Nishijima, MD, MAS","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":5,"role":37},"Nathan Kuppermann, MD, MPH",[41,45],{"name":36,"role":42,"phone":43,"phoneExt":33,"email":44},"CONTACT","916.734.3884","dnishijima@ucdavis.edu",{"name":39,"role":42,"phone":46,"phoneExt":33,"email":47},"916.734.1535","nkuppermann@ucdavis.edu",{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"SPONSOR_INVESTIGATOR","Daniel Nishijima, MD, MAS","Associate Professor",[53],{"name":54,"class":55},"Pediatric Emergency Care Applied Research Network","NETWORK","100392231","phase-3-traumatic-injury-clinical-trial-evaluating-tranexamic-acid-in-children-an-efficacy-study-100392231",false,"NCT04387305","Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children: An Efficacy Study","Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children (TIC-TOC): An Efficacy Study","TIC-TOC","Inclusion Criteria:\n\n1. Less than 18 years old AND\n2. Penetrating torso trauma, blunt torso trauma, or head trauma as defined below:\n3. Penetrating Torso Trauma:\n\n   a. Penetrating trauma to the chest, abdomen, neck, or pelvis with at least one of the following:\n   * age-adjusted hypotension, or\n   * age-adjusted tachycardia despite adequate resuscitation fluids, or\n   * radiographic evidence of internal hemorrhage, or\n   * clinician suspicion of ongoing internal hemorrhage\n4. Blunt Torso Trauma:\n\n   1. Clinician suspicion of hemorrhagic blunt torso injury and at least one of the following:\n\n      * age-adjusted hypotension, or\n      * age-adjusted tachycardia despite adequate resuscitation fluids\n   2. Hemothorax on chest tube placement or imaging,\n   3. Clinical suspicion of hemorrhagic blunt torso injury and Intraperitoneal fluid on abdominal ultrasonography (Focused Assessment with Sonography in Trauma),\n   4. Intra-abdominal injury on CT with either contrast extravasation or more than trace intraperitoneal fluid,\n   5. Pelvic fracture with contrast extravasation or hematoma on abdominal\u002Fpelvic CT scan with at least one of the following:\n\n      * Age-adjusted hypotension, or\n      * Age-adjusted tachycardia.\n5. Head Trauma:\n\n   1. Initial Glasgow Coma Scale (GCS) score 3 to 13 with associated intracranial hemorrhage on cranial CT scan (enroll after cranial CT scan)\n\nExclusion Criteria:\n\n* Unable to administer study drug within 3 hours of traumatic event\n* Known pregnancy\n* Known ward of the state\n* Cardiac arrest prior to randomization\n* GCS score of 3 with bilateral unresponsive pupils\n* Isolated subarachnoid hemorrhage, epidural hematoma, or diffuse axonal injury\n* Known venous or arterial thrombosis\n* Known bleeding\u002Fclotting disorders\n* Known seizure disorders\n* Known history of severe renal impairment\n* Known allergy to TXA\n* Unknown time of injury (includes suspected non-accidental trauma)\n* Previous enrollment into the TIC-TOC trial\n* Prior TXA for current injury\n* Prior opt-out\n* Non-English and non-Spanish speaking","ALL","0 Years","17 Years",{"count":68,"type":69},2000,"ESTIMATED","INTERVENTIONAL",[72],"PHASE3","Trauma is the leading cause of death and disability in children in the United States. The objective of this study is to evaluate the benefits and harms of tranexamic acid (TXA; a drug that stops bleeding) in severely injured children with hemorrhagic brain and\u002For torso injuries. Using thromboelastography, we will measure baseline fibrinolysis to assess for treatment effects of TXA at different levels of fibrinolysis.",[75,76,77,78],"Brain Injuries, Traumatic","Wounds and Injury","Hemorrhage","Trauma Injury",[80,81,77,82,83,84,85],"Tranexamic acid","Brain Injuries","Clinical Trial","Children","Pediatric","Trauma","NOT_YET_RECRUITING","2025-12-09",{"date":89,"type":90},"2025-12-15","ACTUAL",{"date":92,"type":69},"2026-10-01",{"date":94,"type":69},"2031-03-31",{"name":50,"class":6}]