Hemorrhage Clinical Trial
— TIC-TOCOfficial title:
Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children (TIC-TOC): An Efficacy Study
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/or torso injuries. Using thromboelastography, we will measure baseline fibrinolysis to assess for treatment effects of TXA at different levels of fibrinolysis.
Status | Not yet recruiting |
Enrollment | 2000 |
Est. completion date | March 31, 2030 |
Est. primary completion date | March 31, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Years to 17 Years |
Eligibility | Inclusion Criteria: 1. Less than 18 years old AND 2. Penetrating torso trauma, blunt torso trauma, or head trauma as defined below: 3. Penetrating Torso Trauma: a. Penetrating trauma to the chest, abdomen, neck, or pelvis with at least one of the following: - age-adjusted hypotension, or - age-adjusted tachycardia despite adequate resuscitation fluids, or - radiographic evidence of internal hemorrhage, or - clinician suspicion of ongoing internal hemorrhage 4. Blunt Torso Trauma: 1. Clinician suspicion of hemorrhagic blunt torso injury and at least one of the following: - age-adjusted hypotension, or - age-adjusted tachycardia despite adequate resuscitation fluids 2. Hemothorax on chest tube placement or imaging, 3. Clinical suspicion of hemorrhagic blunt torso injury and Intraperitoneal fluid on abdominal ultrasonography (Focused Assessment with Sonography in Trauma), 4. Intra-abdominal injury on CT with either contrast extravasation or more than trace intraperitoneal fluid, 5. Pelvic fracture with contrast extravasation or hematoma on abdominal/pelvic CT scan with at least one of the following: - Age-adjusted hypotension, or - Age-adjusted tachycardia. 5. Head Trauma: 1. Initial Glasgow Coma Scale (GCS) score 3 to 13 with associated intracranial hemorrhage on cranial CT scan (enroll after cranial CT scan) Exclusion Criteria: - Unable to administer study drug within 3 hours of traumatic event - Known pregnancy - Known ward of the state - Cardiac arrest prior to randomization - GCS score of 3 with bilateral unresponsive pupils - Isolated subarachnoid hemorrhage, epidural hematoma, or diffuse axonal injury - Known venous or arterial thrombosis - Known bleeding/clotting disorders - Known seizure disorders - Known history of severe renal impairment - Known allergy to TXA - Unknown time of injury (includes suspected non-accidental trauma) - Previous enrollment into the TIC-TOC trial - Prior TXA for current injury - Prior opt-out - Non-English and non-Spanish speaking |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Daniel Nishijima, MD, MAS | Pediatric Emergency Care Applied Research Network |
Nishijima DK, Gosdin M, Naz H, Tancredi DJ, Hewes HA, Myers SR, Stanley RM, Adelson PD, Burd RS, Finkelstein Y, VanBuren J, Casper TC, Kuppermann N; TIC-TOC Collaborators of the Pediatric Emergency Care Applied Research Network (PECARN). Assessment of pri — View Citation
Powers PE, Shore KK, Perez S, Ritley D, Kuppermann N, Holmes JF, Tzimenatos LS, Shawargga H, Nishijima DK. Public Deliberation as a Novel Method for an Exception From Informed Consent Community Consultation. Acad Emerg Med. 2019 Oct;26(10):1158-1168. doi: — View Citation
Trappey AF 3rd, Thompson KM, Kuppermann N, Stephenson JT, Nuno MA, Hewes HA, Meyers SR, Stanley RM, Galante JM, Nishijima DK; Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children (TIC-TOC) Collaborators of the Pediatric Emergency Care Ap — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Glasgow Outcome Scale-Extended (GOS-E) Peds | Global functioning as measured on an 8-point scale (8-death, 7-vegetative state, 6-lower severe disability, 5-upper severe disability, 4-lower moderate disability, 3-upper moderate disability, 2-lower good recovery, 1-upper good recovery) | 1 week, 1 month, 3 months, and 6 months | |
Other | Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale | Fatigue and cognitive function; 0 to 100 with higher scores representing better outcomes | 1 week, 1 month, 3 months, and 6 months | |
Other | D-dimer | Measure clot breakdown (ng/mL) | Change from baseline to end of 8-hour study drug infusion | |
Other | Plasmin-antiplasmin (PAP) complex | Measure fibrinolytic activity (mcg/L) | Change from baseline to end of 8-hour study drug infusion | |
Other | Tissue plasminogen activator (tPA) | Measure fibrinolytic activity (ng/mL) | Change from baseline to end of 8-hour study drug infusion | |
Other | Thrombosis | Any venous or arterial thrombosis on standard diagnostic imaging post-randomization | 1 week or at hospital discharge (whichever comes first) | |
Other | Seizure | Clinical or electroencephalogram-documented seizure | 1 week or at hospital discharge (whichever comes first) | |
Other | Behavior Rating Inventory of Executive Function (BRIEF) | Measurement of executive function after traumatic brain injury | 6 and 12 months after injury | |
Primary | Pediatric Quality of Life Inventory (PedsQL) area under the curve | Neurocognitive functioning and quality-of-life measure; 0 to 100 with higher scores representing better outcomes | 1 week, 1 month, 3 months, and 6 months (as measured as an area under the curve) | |
Secondary | Intracranial hemorrhage progression | Intracranial hemorrhage progression on cranial computed tomography imaging | 24 hours (±6 hours) | |
Secondary | Blood transfusion | Total volume of packed red blood cells, platelets, fresh frozen plasma, and cryoprecipitate | First 48 hours after randomization | |
Secondary | PedsQL Physical Domain area under the curve | Physical domain of the PedsQL measure; 0 to 100 with higher scores representing better outcomes | 1 week, 1 month, 3 months, and 6 months |
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