Brain Injuries, Hemorrhage, Wounds and Injuries
Conditions
Keywords
Brain injuries, Wounds and injuries, Hemorrhage, Tranexamic acid, Child
Brief summary
Trauma is the leading cause of death and disability in children in the United States. The long-term goal of this project is to evaluate the benefits and harms of tranexamic acid (TXA; a drug that stops bleeding) in severely injured children. This is a 40-patient pilot study to evaluate the feasibility of two subsequent large-scale studies of TXA in injured children.
Detailed description
Tranexamic acid (TXA), a drug that stops bleeding, is the only drug treatment that improves survival in adults with serious bleeding after injuries. However, TXA has not been used routinely in children with traumatic bleeding because no studies have appropriately evaluated TXA for injured children. Such a study has the potential for significant impact in improving the lives of injured children and their families, if found to be successful. The long-term objective is to evaluate the benefits and risks of TXA in severely injured children. This will be achieved by ultimately conducting two large-scale, multicenter, randomized controlled trials of TXA use in severely injured children. One trial will evaluate TXA in children with severe injuries to the body (torso injuries, i.e., to the abdomen and chest) and the second trial will evaluate TXA in children with moderate-to-severe traumatic brain injuries (TBIs). However, conducting a clinical trial in critically ill children is challenging due to lower disease frequency and complex parent consent/child assent procedures. The investigators will conduct a pilot study, designed similarly to the full-scale trials but with much smaller patient enrollment, to assess the feasibility of, and fill crucial information gaps for the two subsequent large-scale clinical trials. Injured children will be randomized to one of three study arms: two different TXA doses or placebo. The specific aim of the proposed pilot study is to demonstrate the ability to efficiently identify and enroll children with hemorrhagic torso injuries or TBIs into a multicenter, randomized controlled pilot study evaluating these two doses of TXA and placebo. The pilot study will enroll 40 children who meet inclusion and exclusion criteria at 4 participating sites. To demonstrate the ability to collect outcome measures, the investigators will collect the identical anticipated outcome measures for the subsequent clinical trials: total blood products transfused over the initial 48 hours of care (torso injury trial), and intracranial hemorrhage progression in first 24 hours and neurocognitive function at 6 months after randomization (TBI trial). The investigators will also collect safety outcomes, specifically venothromboembolic events (i.e., blot clots in the blood vessels) and seizures within the initial 24 hours of study drug. Additional objectives of this pilot study are to: evaluate the ability to efficiently screen, identify, consent, randomize, and initiate the study intervention within 3 hours of injury, assess protocol adherence and variability of care in enrolled patients, and identify operational efficiencies with the potential to enhance the success of the subsequent trials.
Interventions
DRUGTranexamic Acid
Active drug is provided to participants as described based on the TXA arm they are randomized to.
DRUGPlacebo
Normal saline is provided to participants if randomized to this treatment arm.
Sponsors
Pediatric Emergency Care Applied Research Network
Daniel Nishijima, MD, MAS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
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, 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 4. Blunt Torso Trauma (at least one of the following): 1. 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 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 tachycardia, or * Age-adjusted hypotension. 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
1. Unable to administer study drug within 3 hours of traumatic event 2. Known pregnancy 3. Known prisoners 4. Known wards of the state 5. Cardiac arrest prior to randomization 6. GCS score of 3 with bilateral unresponsive pupils 7. Isolated subarachnoid hemorrhage, epidural hematoma, or diffuse axonal injury 8. Known bleeding/clotting disorders 9. Known seizure disorders 10. Known history of severe renal impairment 11. Unknown time of injury 12. Previous enrollment into the TIC-TOC trial 13. Prior TXA for current injury 14. Non-English and non-Spanish speaking 15. Known venous or arterial thrombosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Quality of Life Inventory (PedsQL) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Digit Span Recall Test | 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 | First 48 hours after randomization | Total volume of packed red blood cells, platelets, fresh frozen plasma, and cryoprecipitate |
| Intracranial Hemorrhage Progression | 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. |
| Glasgow Outcome Scale-Extended (GOS-E) Peds | 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 |
| Number of Participants With Seizures | 24 hours after receiving drug | Clinical or electroencephalogram-documented |
| Biomarker Testing | Baseline and completion of 8 hour infusion | Changes in coagulation biomarkers due to study intervention |
| Number of Participants With Any Non-cerebral Venous or Arterial Thrombosis | Day 7 of hospitalization or hospital discharge (whichever comes first) | Any non-cerebral venous or arterial thrombosis on standard diagnostic imaging post-randomization |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Tranexamic Acid: Active drug is provided to participants as described based on the TXA arm they are randomized to. | 9 |
| 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.
Tranexamic Acid: Active drug is provided to participants as described based on the TXA arm they are randomized to. | 10 |
| 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.
Placebo: Normal saline is provided to participants if randomized to this treatment arm. | 12 |
| Total | 31 |
Baseline characteristics
| Characteristic | Total | Tranexamic Acid Dose A | Placebo | Tranexamic Acid Dose B |
|---|---|---|---|---|
| Age, Continuous | 10.7 years STANDARD_DEVIATION 5 | 12.6 years STANDARD_DEVIATION 4.4 | 9.2 years STANDARD_DEVIATION 6.1 | 10.7 years STANDARD_DEVIATION 4 |
| Creatinine | 0.7 mg/dL STANDARD_DEVIATION 0.3 | 0.7 mg/dL STANDARD_DEVIATION 0.2 | 0.6 mg/dL STANDARD_DEVIATION 0.3 | 0.6 mg/dL STANDARD_DEVIATION 0.2 |
| Emergency department disposition Admit | 24 Participants | 6 Participants | 9 Participants | 9 Participants |
| Emergency department disposition Operating room | 7 Participants | 3 Participants | 3 Participants | 1 Participants |
| Glomerular filtration rate () Moderate renal dysfunction | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Glomerular filtration rate () Normal renal function | 30 Participants | 9 Participants | 11 Participants | 10 Participants |
| Hemoglobin | 12.8 g/dL STANDARD_DEVIATION 1.7 | 13.0 g/dL STANDARD_DEVIATION 1.1 | 12.5 g/dL STANDARD_DEVIATION 2 | 13.1 g/dL STANDARD_DEVIATION 1.9 |
| Initial Glasgow Coma Scale score (3 to 15) TBI/Both | 9 units on a scale | 13 units on a scale | 3 units on a scale | 11 units on a scale |
| Initial Glasgow Coma Scale score (3 to 15) Torso | 15 units on a scale | 15 units on a scale | 15 units on a scale | 15 units on a scale |
| Injury Severity Scale score (0 to 75) | 14.6 units on a scale STANDARD_DEVIATION 5.6 | 15.1 units on a scale STANDARD_DEVIATION 5.8 | 13.8 units on a scale STANDARD_DEVIATION 5.7 | 15.2 units on a scale STANDARD_DEVIATION 5.7 |
| Injury Type TBI | 16 Participants | 4 Participants | 7 Participants | 5 Participants |
| Injury Type Torso | 15 Participants | 5 Participants | 5 Participants | 5 Participants |
| International Normalized Ratio | 1.1 ratio STANDARD_DEVIATION 0.2 | 1.1 ratio STANDARD_DEVIATION 0.1 | 1.2 ratio STANDARD_DEVIATION 0.2 | 1.1 ratio STANDARD_DEVIATION 0.2 |
| Length of hospitalization | 15.4 days STANDARD_DEVIATION 20.2 | 8.3 days STANDARD_DEVIATION 8 | 22.3 days STANDARD_DEVIATION 28.2 | 13.6 days STANDARD_DEVIATION 14.7 |
| Method of transport to the emergency department EMS air | 10 Participants | 1 Participants | 5 Participants | 4 Participants |
| Method of transport to the emergency department EMS ground | 17 Participants | 8 Participants | 4 Participants | 5 Participants |
| Method of transport to the emergency department Interfacility transfer | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Method of transport to the emergency department Multiple methods of transportation | 2 Participants | 0 Participants | 1 Participants | 1 Participants |
| Method of transport to the emergency department Private vehicle/walk-in | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Patient received a laparotomy | 8 Participants | 3 Participants | 3 Participants | 2 Participants |
| Patient received an intracranial pressure monitor | 4 Participants | 0 Participants | 3 Participants | 1 Participants |
| Patient received a thoracotomy | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Patient received craniotomy or craniectomy | 3 Participants | 0 Participants | 2 Participants | 1 Participants |
| pH | 7.3 units on a scale STANDARD_DEVIATION 0.1 | 7.3 units on a scale STANDARD_DEVIATION 0.1 | 7.3 units on a scale STANDARD_DEVIATION 0.1 | 7.3 units on a scale STANDARD_DEVIATION 0.1 |
| Platelets | 329.7 platelets per microliter STANDARD_DEVIATION 133.6 | 323.5 platelets per microliter STANDARD_DEVIATION 117.9 | 374.7 platelets per microliter STANDARD_DEVIATION 138.7 | 285.0 platelets per microliter STANDARD_DEVIATION 136.5 |
| Presence of peritoneal free fluid on initial focused assessment with sonography for trauma exam | 4 Participants | 1 Participants | 1 Participants | 2 Participants |
| Primary mechanism of injury Fall from greater than standing height | 5 Participants | 1 Participants | 2 Participants | 2 Participants |
| Primary mechanism of injury Gun-shot wound | 4 Participants | 2 Participants | 2 Participants | 0 Participants |
| Primary mechanism of injury MVC | 9 Participants | 3 Participants | 2 Participants | 4 Participants |
| Primary mechanism of injury Other | 3 Participants | 0 Participants | 1 Participants | 2 Participants |
| Primary mechanism of injury Pedestrian/bicyclist hit by moving vehicle | 4 Participants | 1 Participants | 3 Participants | 0 Participants |
| Primary mechanism of injury Recreational vehicle injury | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Primary mechanism of injury Sport-related injury | 5 Participants | 2 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 2 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 16 Participants | 4 Participants | 6 Participants | 6 Participants |
| Serum bicarbonate | 21.4 mmol/L STANDARD_DEVIATION 2.5 | 20.4 mmol/L STANDARD_DEVIATION 2.2 | 21.5 mmol/L STANDARD_DEVIATION 3.2 | 22.0 mmol/L STANDARD_DEVIATION 1.7 |
| Sex: Female, Male Female | 9 Participants | 4 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 22 Participants | 5 Participants | 9 Participants | 8 Participants |
| Time from injury to emergency department arrival | 1.0 hours STANDARD_DEVIATION 0.6 | 0.8 hours STANDARD_DEVIATION 0.5 | 1.1 hours STANDARD_DEVIATION 0.8 | 1.2 hours STANDARD_DEVIATION 0.5 |
| Time from injury to randomization | 2.4 hours STANDARD_DEVIATION 0.6 | 2.3 hours STANDARD_DEVIATION 0.5 | 2.4 hours STANDARD_DEVIATION 0.7 | 2.5 hours STANDARD_DEVIATION 0.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 10 | 0 / 12 |
| other Total, other adverse events | 9 / 9 | 10 / 10 | 10 / 12 |
| serious Total, serious adverse events | 0 / 9 | 0 / 10 | 1 / 12 |
Outcome results
Primary
Pediatric Quality of Life Inventory (PedsQL)
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tranexamic Acid Dose A | Pediatric Quality of Life Inventory (PedsQL) | 64.9 Quality of life units * months | Standard Deviation 19 |
| Tranexamic Acid Dose B | Pediatric Quality of Life Inventory (PedsQL) | 60.2 Quality of life units * months | Standard Deviation 12.3 |
| Placebo | Pediatric Quality of Life Inventory (PedsQL) | 67.2 Quality of life units * months | Standard Deviation 20 |
Primary
Pediatric Quality of Life Inventory (PedsQL)
Neurocognitive functioning and quality-of-life measures; range from 0 to 100 with higher scores representing better outcomes
Time frame: 1 week, 1 month, 3 months, and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tranexamic Acid Dose A | Pediatric Quality of Life Inventory (PedsQL) | 1 week | 43.7 units on a scale | Standard Deviation 24 |
| Tranexamic Acid Dose A | Pediatric Quality of Life Inventory (PedsQL) | 1 month | 57.0 units on a scale | Standard Deviation 19.8 |
| Tranexamic Acid Dose A | Pediatric Quality of Life Inventory (PedsQL) | 3 months | 77.3 units on a scale | Standard Deviation 23.6 |
| Tranexamic Acid Dose A | Pediatric Quality of Life Inventory (PedsQL) | 6 months | 81.6 units on a scale | Standard Deviation 23 |
| Tranexamic Acid Dose B | Pediatric Quality of Life Inventory (PedsQL) | 6 months | 84.3 units on a scale | Standard Deviation 9.9 |
| Tranexamic Acid Dose B | Pediatric Quality of Life Inventory (PedsQL) | 1 week | 52.4 units on a scale | Standard Deviation 20.1 |
| Tranexamic Acid Dose B | Pediatric Quality of Life Inventory (PedsQL) | 3 months | 77.5 units on a scale | Standard Deviation 18.5 |
| Tranexamic Acid Dose B | Pediatric Quality of Life Inventory (PedsQL) | 1 month | 61.5 units on a scale | Standard Deviation 16.9 |
| Placebo | Pediatric Quality of Life Inventory (PedsQL) | 6 months | 68.9 units on a scale | Standard Deviation 25.9 |
| Placebo | Pediatric Quality of Life Inventory (PedsQL) | 1 month | 60.5 units on a scale | Standard Deviation 27.9 |
| Placebo | Pediatric Quality of Life Inventory (PedsQL) | 3 months | 68.9 units on a scale | Standard Deviation 22.5 |
| Placebo | Pediatric Quality of Life Inventory (PedsQL) | 1 week | 57.9 units on a scale | Standard Deviation 28.6 |
Secondary
Biomarker Testing
Changes in coagulation biomarkers due to study intervention
Time frame: Baseline and completion of 8 hour infusion
Population: Data were not collected
Secondary
Blood Transfusion
Total volume of packed red blood cells, platelets, fresh frozen plasma, and cryoprecipitate
Time frame: First 48 hours after randomization
Population: Torso and Both groups
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tranexamic Acid Dose A | Blood Transfusion | 367.4 ml | Standard Deviation 821.5 |
| Tranexamic Acid Dose B | Blood Transfusion | 150.4 ml | Standard Deviation 214.1 |
| Placebo | Blood Transfusion | 303.6 ml | Standard Deviation 571.9 |
Secondary
Digit Span Recall Test
Test of working memory; higher scores represent a better outcome, range from 0 to infinity
Time frame: 1 week, 1 month, 3 months, and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tranexamic Acid Dose A | Digit Span Recall Test | Total backward digit span, 3 months | 8.7 score on a scale | Standard Deviation 3.6 |
| Tranexamic Acid Dose A | Digit Span Recall Test | Total backward digit span, 1 month | 6.2 score on a scale | Standard Deviation 1.8 |
| Tranexamic Acid Dose A | Digit Span Recall Test | Total backward digit span, 6 months | 10.4 score on a scale | Standard Deviation 4.1 |
| Tranexamic Acid Dose A | Digit Span Recall Test | Total forward digit span, 3 months | 9.1 score on a scale | Standard Deviation 3.6 |
| Tranexamic Acid Dose A | Digit Span Recall Test | Total forward digit span, 1 week | 8.4 score on a scale | Standard Deviation 1.7 |
| Tranexamic Acid Dose A | Digit Span Recall Test | Total forward digit span, 6 months | 11.7 score on a scale | Standard Deviation 3.9 |
| Tranexamic Acid Dose A | Digit Span Recall Test | Total forward digit span, 1 month | 7.2 score on a scale | Standard Deviation 1.9 |
| Tranexamic Acid Dose A | Digit Span Recall Test | Total backward digit span, 1 week | 6.0 score on a scale | Standard Deviation 1.6 |
| Tranexamic Acid Dose B | Digit Span Recall Test | Total forward digit span, 1 week | 8.4 score on a scale | Standard Deviation 4.3 |
| Tranexamic Acid Dose B | Digit Span Recall Test | Total backward digit span, 1 week | 6.0 score on a scale | Standard Deviation 3.3 |
| Tranexamic Acid Dose B | Digit Span Recall Test | Total forward digit span, 1 month | 7.9 score on a scale | Standard Deviation 3.7 |
| Tranexamic Acid Dose B | Digit Span Recall Test | Total backward digit span, 1 month | 6.2 score on a scale | Standard Deviation 1.3 |
| Tranexamic Acid Dose B | Digit Span Recall Test | Total forward digit span, 3 months | 10.4 score on a scale | Standard Deviation 1.5 |
| Tranexamic Acid Dose B | Digit Span Recall Test | Total backward digit span, 3 months | 7.8 score on a scale | Standard Deviation 0.8 |
| Tranexamic Acid Dose B | Digit Span Recall Test | Total forward digit span, 6 months | 10.0 score on a scale | Standard Deviation 2.4 |
| Tranexamic Acid Dose B | Digit Span Recall Test | Total backward digit span, 6 months | 6.0 score on a scale | Standard Deviation 2.4 |
| Placebo | Digit Span Recall Test | Total forward digit span, 1 week | 8.8 score on a scale | Standard Deviation 2.8 |
| Placebo | Digit Span Recall Test | Total backward digit span, 3 months | 6.5 score on a scale | Standard Deviation 1.1 |
| Placebo | Digit Span Recall Test | Total backward digit span, 1 week | 7.3 score on a scale | Standard Deviation 1 |
| Placebo | Digit Span Recall Test | Total backward digit span, 6 months | 5.8 score on a scale | Standard Deviation 2.9 |
| Placebo | Digit Span Recall Test | Total backward digit span, 1 month | 5.3 score on a scale | Standard Deviation 2.6 |
| Placebo | Digit Span Recall Test | Total forward digit span, 6 months | 8.4 score on a scale | Standard Deviation 2.3 |
| Placebo | Digit Span Recall Test | Total forward digit span, 3 months | 8.6 score on a scale | Standard Deviation 2.5 |
| Placebo | Digit Span Recall Test | Total forward digit span, 1 month | 7.5 score on a scale | Standard Deviation 2.6 |
Secondary
Glasgow Outcome Scale-Extended (GOS-E) Peds
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
Time frame: 1 week, 1 month, 3 months, and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tranexamic Acid Dose A | Glasgow Outcome Scale-Extended (GOS-E) Peds | 1 week | 4.6 score on a scale | Standard Deviation 2.3 |
| Tranexamic Acid Dose A | Glasgow Outcome Scale-Extended (GOS-E) Peds | 1 month | 4.9 score on a scale | Standard Deviation 2 |
| Tranexamic Acid Dose A | Glasgow Outcome Scale-Extended (GOS-E) Peds | 3 months | 3.8 score on a scale | Standard Deviation 2.3 |
| Tranexamic Acid Dose A | Glasgow Outcome Scale-Extended (GOS-E) Peds | 6 months | 3.7 score on a scale | Standard Deviation 2.6 |
| Tranexamic Acid Dose B | Glasgow Outcome Scale-Extended (GOS-E) Peds | 6 months | 2.9 score on a scale | Standard Deviation 2.3 |
| Tranexamic Acid Dose B | Glasgow Outcome Scale-Extended (GOS-E) Peds | 1 week | 5.2 score on a scale | Standard Deviation 1.8 |
| Tranexamic Acid Dose B | Glasgow Outcome Scale-Extended (GOS-E) Peds | 3 months | 4.6 score on a scale | Standard Deviation 1.3 |
| Tranexamic Acid Dose B | Glasgow Outcome Scale-Extended (GOS-E) Peds | 1 month | 5.1 score on a scale | Standard Deviation 1.4 |
| Placebo | Glasgow Outcome Scale-Extended (GOS-E) Peds | 6 months | 4.3 score on a scale | Standard Deviation 2.3 |
| Placebo | Glasgow Outcome Scale-Extended (GOS-E) Peds | 1 month | 4.5 score on a scale | Standard Deviation 2.2 |
| Placebo | Glasgow Outcome Scale-Extended (GOS-E) Peds | 3 months | 4.2 score on a scale | Standard Deviation 2.4 |
| Placebo | Glasgow Outcome Scale-Extended (GOS-E) Peds | 1 week | 5.3 score on a scale | Standard Deviation 2.2 |
Secondary
Intracranial Hemorrhage Progression
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.
Time frame: 24 hours (±6 hours)
Population: Brain Injury and Both groups
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tranexamic Acid Dose A | Intracranial Hemorrhage Progression | 0.003 Proportional change | Standard Deviation 0.004 |
| Tranexamic Acid Dose B | Intracranial Hemorrhage Progression | 0.001 Proportional change | Standard Deviation 0.001 |
| Placebo | Intracranial Hemorrhage Progression | 0.003 Proportional change | Standard Deviation 0.013 |
Secondary
Number of Participants With Any Non-cerebral Venous or Arterial Thrombosis
Any non-cerebral venous or arterial thrombosis on standard diagnostic imaging post-randomization
Time frame: Day 7 of hospitalization or hospital discharge (whichever comes first)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tranexamic Acid Dose A | Number of Participants With Any Non-cerebral Venous or Arterial Thrombosis | 0 Participants |
| Tranexamic Acid Dose B | Number of Participants With Any Non-cerebral Venous or Arterial Thrombosis | 0 Participants |
| Placebo | Number of Participants With Any Non-cerebral Venous or Arterial Thrombosis | 0 Participants |
Secondary
Number of Participants With Seizures
Clinical or electroencephalogram-documented
Time frame: 24 hours after receiving drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tranexamic Acid Dose A | Number of Participants With Seizures | 0 Participants |
| Tranexamic Acid Dose B | Number of Participants With Seizures | 0 Participants |
| Placebo | Number of Participants With Seizures | 1 Participants |