Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children: A Pilot and Feasibility Study (TIC-TOC)
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ClinicalTrials.gov Identifier: NCT02840097 |
Recruitment Status :
Completed
First Posted : July 21, 2016
Results First Posted : September 5, 2021
Last Update Posted : September 5, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Brain Injuries Wounds and Injuries Hemorrhage | Drug: Tranexamic Acid Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 31 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children (TIC-TOC): A Pilot and Feasibility Study |
Actual Study Start Date : | March 4, 2019 |
Actual Primary Completion Date : | October 3, 2020 |
Actual Study Completion Date : | October 3, 2020 |

Arm | Intervention/treatment |
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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.
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Drug: Tranexamic Acid
Active drug is provided to participants as described based on the TXA arm they are randomized to.
Other Name: TXA |
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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Drug: Tranexamic Acid
Active drug is provided to participants as described based on the TXA arm they are randomized to.
Other Name: TXA |
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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Drug: Placebo
Normal saline is provided to participants if randomized to this treatment arm.
Other Name: 0.9% Normal Saline |
- Pediatric Quality of Life Inventory (PedsQL) [ Time Frame: 6 months ]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.
- Pediatric Quality of Life Inventory (PedsQL) [ Time Frame: 1 week, 1 month, 3 months, and 6 months ]Neurocognitive functioning and quality-of-life measures; range from 0 to 100 with higher scores representing better outcomes
- Glasgow Outcome Scale-Extended (GOS-E) Peds [ Time Frame: 1 week, 1 month, 3 months, and 6 months ]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
- Digit Span Recall Test [ Time Frame: 1 week, 1 month, 3 months, and 6 months ]Test of working memory; higher scores represent a better outcome, range from 0 to infinity
- Blood Transfusion [ Time Frame: First 48 hours after randomization ]Total volume of packed red blood cells, platelets, fresh frozen plasma, and cryoprecipitate
- Intracranial Hemorrhage Progression [ Time Frame: 24 hours (±6 hours) ]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.
- Number of Participants With Any Non-cerebral Venous or Arterial Thrombosis [ Time Frame: Day 7 of hospitalization or hospital discharge (whichever comes first) ]Any non-cerebral venous or arterial thrombosis on standard diagnostic imaging post-randomization
- Number of Participants With Seizures [ Time Frame: 24 hours after receiving drug ]Clinical or electroencephalogram-documented
- Biomarker Testing [ Time Frame: Baseline and completion of 8 hour infusion ]Changes in coagulation biomarkers due to study intervention

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | up to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Less than 18 years old AND
- Penetrating torso trauma, blunt torso trauma, or head trauma as defined below.
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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
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Blunt Torso Trauma (at least one of the following):
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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,
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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.
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840097
United States, California | |
University of California, Davis | |
Sacramento, California, United States, 95817 | |
United States, Ohio | |
Nationwide Children's Hospital | |
Columbus, Ohio, United States, 43205 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Utah | |
Primary Children's Hospital | |
Salt Lake City, Utah, United States, 84113 |
Principal Investigator: | Daniel K Nishijima, MD, MAS | University of California, Davis |
Documents provided by Daniel Nishijima, MD, MAS, University of California, Davis:
Publications of Results:
Responsible Party: | Daniel Nishijima, MD, MAS, Associate Professor, Emergency Medicine, University of California, Davis |
ClinicalTrials.gov Identifier: | NCT02840097 |
Other Study ID Numbers: |
1023599 |
First Posted: | July 21, 2016 Key Record Dates |
Results First Posted: | September 5, 2021 |
Last Update Posted: | September 5, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Brain injuries Wounds and injuries Hemorrhage Tranexamic acid Child |
Brain Injuries Hemorrhage Wounds and Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System |
Pathologic Processes Tranexamic Acid Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |