- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02840097
Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children: A Pilot and Feasibility Study (TIC-TOC)
Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children (TIC-TOC): A Pilot and Feasibility Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Sacramento, California, United States, 95817
- University of California, Davis
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Ohio
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Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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Utah
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Salt Lake City, Utah, United States, 84113
- Primary Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Less than 18 years old AND
- Penetrating torso trauma, blunt torso trauma, or head trauma as defined below.
Penetrating Torso Trauma:
a. Penetrating trauma to the chest, abdomen, neck, pelvis or thigh 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
Blunt Torso Trauma (at least one of the following):
Clinician suspicion of hemorrhagic blunt torso injury and at least one of the following:
- age-adjusted hypotension, or
- persistent age-adjusted tachycardia despite adequate resuscitation fluids
- Hemothorax on chest tube placement or imaging,
- Clinical suspicion of hemorrhagic blunt torso injury and Intraperitoneal fluid on abdominal ultrasonography (Focused Assessment with Sonography in Trauma),
- Intra-abdominal injury on CT with either contrast extravasation or more than trace intraperitoneal fluid,
Pelvic fracture with contrast extravasation or hematoma on abdominal/pelvic CT scan with at least one of the following:
- Age-adjusted tachycardia, or
- Age-adjusted hypotension.
Head Trauma:
- 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 prisoners
- Known wards 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 bleeding/clotting disorders
- Known seizure disorders
- Known history of severe renal impairment
- Unknown time of injury
- Previous enrollment into the TIC-TOC trial
- Prior TXA for current injury
- Non-English and non-Spanish speaking
- Known venous or arterial thrombosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tranexamic acid dose A
Subjects will receive a 15 mg/kg bolus of tranexamic acid over 10 minutes followed by a 2mg/kg/h over 8 hours.
This represents 31mg/kg total dose of TXA.
|
Active drug is provided to participants as described based on the TXA arm they are randomized to.
Other Names:
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Experimental: Tranexamic acid dose B
Subjects will receive a 30 mg/kg bolus of tranexamic acid over 10 minutes followed by a 4 mg/kg/h over 8 hours.
This represents 62 mg/kg total dose of TXA.
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Active drug is provided to participants as described based on the TXA arm they are randomized to.
Other Names:
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Placebo Comparator: Placebo
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.
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Normal saline is provided to participants if randomized to this treatment arm.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pediatric Quality of Life Inventory (PedsQL)
Time Frame: 6 months
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Neurocognitive functioning and quality-of-life measures; range from 0 to 100 quality of life units with higher scores representing better outcomes.
Measurements occur at 1 week, 1 month, 3 months, and 6 months to generate an area under the curve of quality of life units.
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6 months
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Pediatric Quality of Life Inventory (PedsQL)
Time Frame: 1 week, 1 month, 3 months, and 6 months
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Neurocognitive functioning and quality-of-life measures; range from 0 to 100 with higher scores representing better outcomes
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1 week, 1 month, 3 months, and 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glasgow Outcome Scale-Extended (GOS-E) Peds
Time Frame: 1 week, 1 month, 3 months, and 6 months
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Global functioning; range is 1 to 8 with higher scores representing better outcomes; 1=death, 2=vegetative state, 3=lower severe disability, 4=upper severe disability, 5=lower moderate disability, 6=upper moderate disability, 7=lower good recovery, 8=upper good recovery
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1 week, 1 month, 3 months, and 6 months
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Digit Span Recall Test
Time Frame: 1 week, 1 month, 3 months, and 6 months
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Test of working memory; higher scores represent a better outcome, range from 0 to infinity
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1 week, 1 month, 3 months, and 6 months
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Blood Transfusion
Time Frame: First 48 hours after randomization
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Total volume of packed red blood cells, platelets, fresh frozen plasma, and cryoprecipitate
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First 48 hours after randomization
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Intracranial Hemorrhage Progression
Time Frame: 24 hours (±6 hours)
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Intracranial hemorrhage progression on cranial computed tomography (CT) imaging; hemorrhage will be measured using the ABC/2 volume estimation and relative to the total brain volume (calculated by the XYZ/2 volume estimation); more intracranial hemorrhage progression represents a worse outcome.
Change is calculated as the difference between the baseline and repeat cranial CT imaging.
The repeat CT is conducted 24 hours (±6 hours) after the baseline CT.
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24 hours (±6 hours)
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Number of Participants With Any Non-cerebral Venous or Arterial Thrombosis
Time Frame: Day 7 of hospitalization or hospital discharge (whichever comes first)
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Any non-cerebral venous or arterial thrombosis on standard diagnostic imaging post-randomization
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Day 7 of hospitalization or hospital discharge (whichever comes first)
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Number of Participants With Seizures
Time Frame: 24 hours after receiving drug
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Clinical or electroencephalogram-documented
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24 hours after receiving drug
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Biomarker Testing
Time Frame: Baseline and completion of 8 hour infusion
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Changes in coagulation biomarkers due to study intervention
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Baseline and completion of 8 hour infusion
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Daniel K Nishijima, MD, MAS, University of California, Davis
Publications and helpful links
General Publications
- 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 primary outcome measures for a clinical trial of pediatric hemorrhagic injuries. Am J Emerg Med. 2021 May;43:210-216. doi: 10.1016/j.ajem.2020.03.001. Epub 2020 Mar 9.
- 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 Applied Research Network (PECARN). Development of transfusion guidelines for injured children using a Modified Delphi Consensus Process. J Trauma Acute Care Surg. 2019 Oct;87(4):935-943. doi: 10.1097/TA.0000000000002432. Erratum In: J Trauma Acute Care Surg. 2022 May 1;92(5):949.
- 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: 10.1111/acem.13827. Epub 2019 Jul 24.
- Nishijima DK, VanBuren J, Hewes HA, Myers SR, Stanley RM, Adelson PD, Barnhard SE, Bobinski M, Ghetti S, Holmes JF, Roberts I, Schalick WO 3rd, Tran NK, Tzimenatos LS, Michael Dean J, Kuppermann N; TIC-TOC Collaborators of the Pediatric Emergency Care Applied Research Network. Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): study protocol for a pilot randomized controlled trial. Trials. 2018 Oct 30;19(1):593. doi: 10.1186/s13063-018-2974-z.
- Patel PA, Wyrobek JA, Butwick AJ, Pivalizza EG, Hare GMT, Mazer CD, Goobie SM. Update on Applications and Limitations of Perioperative Tranexamic Acid. Anesth Analg. 2022 Sep 1;135(3):460-473. doi: 10.1213/ANE.0000000000006039. Epub 2022 Aug 17.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Craniocerebral Trauma
- Trauma, Nervous System
- Brain Injuries
- Wounds and Injuries
- Hemorrhage
- Molecular Mechanisms of Pharmacological Action
- Fibrin Modulating Agents
- Antifibrinolytic Agents
- Hemostatics
- Coagulants
- Tranexamic Acid
Other Study ID Numbers
- 1023599
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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