Trial Outcomes & Findings for Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children: A Pilot and Feasibility Study (NCT NCT02840097)
NCT ID: NCT02840097
Last Updated: 2021-09-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
6 months
Results posted on
2021-09-05
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
12
|
|
Overall Study
COMPLETED
|
9
|
10
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children: A Pilot and Feasibility Study
Baseline characteristics by cohort
| Measure |
Tranexamic Acid Dose A
n=9 Participants
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.
|
Tranexamic Acid Dose B
n=10 Participants
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.
|
Placebo
n=12 Participants
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.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
12.6 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
10.7 years
STANDARD_DEVIATION 4.0 • n=7 Participants
|
9.2 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
10.7 years
STANDARD_DEVIATION 5.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Injury Type
TBI
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Injury Type
Torso
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Method of transport to the emergency department
EMS air
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Method of transport to the emergency department
EMS ground
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Method of transport to the emergency department
Private vehicle/walk-in
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Method of transport to the emergency department
Interfacility transfer
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Method of transport to the emergency department
Multiple methods of transportation
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Time from injury to emergency department arrival
|
0.8 hours
STANDARD_DEVIATION 0.5 • n=5 Participants
|
1.2 hours
STANDARD_DEVIATION 0.5 • n=7 Participants
|
1.1 hours
STANDARD_DEVIATION 0.8 • n=5 Participants
|
1.0 hours
STANDARD_DEVIATION 0.6 • n=4 Participants
|
|
Time from injury to randomization
|
2.3 hours
STANDARD_DEVIATION 0.5 • n=5 Participants
|
2.5 hours
STANDARD_DEVIATION 0.4 • n=7 Participants
|
2.4 hours
STANDARD_DEVIATION 0.7 • n=5 Participants
|
2.4 hours
STANDARD_DEVIATION 0.6 • n=4 Participants
|
|
Primary mechanism of injury
Fall from greater than standing height
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Primary mechanism of injury
MVC
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Primary mechanism of injury
Pedestrian/bicyclist hit by moving vehicle
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Primary mechanism of injury
Gun-shot wound
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Primary mechanism of injury
Recreational vehicle injury
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Primary mechanism of injury
Sport-related injury
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Primary mechanism of injury
Other
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Initial Glasgow Coma Scale score (3 to 15)
TBI/Both
|
13 units on a scale
n=5 Participants
|
11 units on a scale
n=7 Participants
|
3 units on a scale
n=5 Participants
|
9 units on a scale
n=4 Participants
|
|
Initial Glasgow Coma Scale score (3 to 15)
Torso
|
15 units on a scale
n=5 Participants
|
15 units on a scale
n=7 Participants
|
15 units on a scale
n=5 Participants
|
15 units on a scale
n=4 Participants
|
|
Emergency department disposition
Operating room
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Emergency department disposition
Admit
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Patient received craniotomy or craniectomy
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Patient received an intracranial pressure monitor
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Patient received a laparotomy
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Patient received a thoracotomy
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Length of hospitalization
|
8.3 days
STANDARD_DEVIATION 8.0 • n=5 Participants
|
13.6 days
STANDARD_DEVIATION 14.7 • n=7 Participants
|
22.3 days
STANDARD_DEVIATION 28.2 • n=5 Participants
|
15.4 days
STANDARD_DEVIATION 20.2 • n=4 Participants
|
|
Injury Severity Scale score (0 to 75)
|
15.1 units on a scale
STANDARD_DEVIATION 5.8 • n=5 Participants
|
15.2 units on a scale
STANDARD_DEVIATION 5.7 • n=7 Participants
|
13.8 units on a scale
STANDARD_DEVIATION 5.7 • n=5 Participants
|
14.6 units on a scale
STANDARD_DEVIATION 5.6 • n=4 Participants
|
|
Presence of peritoneal free fluid on initial focused assessment with sonography for trauma exam
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
pH
|
7.3 units on a scale
STANDARD_DEVIATION 0.1 • n=5 Participants
|
7.3 units on a scale
STANDARD_DEVIATION 0.1 • n=7 Participants
|
7.3 units on a scale
STANDARD_DEVIATION 0.1 • n=5 Participants
|
7.3 units on a scale
STANDARD_DEVIATION 0.1 • n=4 Participants
|
|
Serum bicarbonate
|
20.4 mmol/L
STANDARD_DEVIATION 2.2 • n=5 Participants
|
22.0 mmol/L
STANDARD_DEVIATION 1.7 • n=7 Participants
|
21.5 mmol/L
STANDARD_DEVIATION 3.2 • n=5 Participants
|
21.4 mmol/L
STANDARD_DEVIATION 2.5 • n=4 Participants
|
|
Creatinine
|
0.7 mg/dL
STANDARD_DEVIATION 0.2 • n=5 Participants
|
0.6 mg/dL
STANDARD_DEVIATION 0.2 • n=7 Participants
|
0.6 mg/dL
STANDARD_DEVIATION 0.3 • n=5 Participants
|
0.7 mg/dL
STANDARD_DEVIATION 0.3 • n=4 Participants
|
|
International Normalized Ratio
|
1.1 ratio
STANDARD_DEVIATION 0.1 • n=5 Participants
|
1.1 ratio
STANDARD_DEVIATION 0.2 • n=7 Participants
|
1.2 ratio
STANDARD_DEVIATION 0.2 • n=5 Participants
|
1.1 ratio
STANDARD_DEVIATION 0.2 • n=4 Participants
|
|
Hemoglobin
|
13.0 g/dL
STANDARD_DEVIATION 1.1 • n=5 Participants
|
13.1 g/dL
STANDARD_DEVIATION 1.9 • n=7 Participants
|
12.5 g/dL
STANDARD_DEVIATION 2.0 • n=5 Participants
|
12.8 g/dL
STANDARD_DEVIATION 1.7 • n=4 Participants
|
|
Platelets
|
323.5 platelets per microliter
STANDARD_DEVIATION 117.9 • n=5 Participants
|
285.0 platelets per microliter
STANDARD_DEVIATION 136.5 • n=7 Participants
|
374.7 platelets per microliter
STANDARD_DEVIATION 138.7 • n=5 Participants
|
329.7 platelets per microliter
STANDARD_DEVIATION 133.6 • n=4 Participants
|
|
Glomerular filtration rate ()
Moderate renal dysfunction
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Glomerular filtration rate ()
Normal renal function
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 monthsNeurocognitive 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.
Outcome measures
| Measure |
Placebo
n=12 Participants
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.
|
Tranexamic Acid Dose A
n=9 Participants
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.
|
Tranexamic Acid Dose B
n=10 Participants
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.
|
|---|---|---|---|
|
Pediatric Quality of Life Inventory (PedsQL)
|
67.2 Quality of life units * months
Standard Deviation 20.0
|
64.9 Quality of life units * months
Standard Deviation 19.0
|
60.2 Quality of life units * months
Standard Deviation 12.3
|
PRIMARY outcome
Timeframe: 1 week, 1 month, 3 months, and 6 monthsNeurocognitive functioning and quality-of-life measures; range from 0 to 100 with higher scores representing better outcomes
Outcome measures
| Measure |
Placebo
n=12 Participants
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.
|
Tranexamic Acid Dose A
n=9 Participants
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.
|
Tranexamic Acid Dose B
n=10 Participants
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.
|
|---|---|---|---|
|
Pediatric Quality of Life Inventory (PedsQL)
1 week
|
57.9 units on a scale
Standard Deviation 28.6
|
43.7 units on a scale
Standard Deviation 24.0
|
52.4 units on a scale
Standard Deviation 20.1
|
|
Pediatric Quality of Life Inventory (PedsQL)
1 month
|
60.5 units on a scale
Standard Deviation 27.9
|
57.0 units on a scale
Standard Deviation 19.8
|
61.5 units on a scale
Standard Deviation 16.9
|
|
Pediatric Quality of Life Inventory (PedsQL)
3 months
|
68.9 units on a scale
Standard Deviation 22.5
|
77.3 units on a scale
Standard Deviation 23.6
|
77.5 units on a scale
Standard Deviation 18.5
|
|
Pediatric Quality of Life Inventory (PedsQL)
6 months
|
68.9 units on a scale
Standard Deviation 25.9
|
81.6 units on a scale
Standard Deviation 23.0
|
84.3 units on a scale
Standard Deviation 9.9
|
SECONDARY outcome
Timeframe: 1 week, 1 month, 3 months, and 6 monthsGlobal 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
Outcome measures
| Measure |
Placebo
n=12 Participants
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.
|
Tranexamic Acid Dose A
n=9 Participants
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.
|
Tranexamic Acid Dose B
n=10 Participants
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.
|
|---|---|---|---|
|
Glasgow Outcome Scale-Extended (GOS-E) Peds
1 week
|
5.3 score on a scale
Standard Deviation 2.2
|
4.6 score on a scale
Standard Deviation 2.3
|
5.2 score on a scale
Standard Deviation 1.8
|
|
Glasgow Outcome Scale-Extended (GOS-E) Peds
1 month
|
4.5 score on a scale
Standard Deviation 2.2
|
4.9 score on a scale
Standard Deviation 2.0
|
5.1 score on a scale
Standard Deviation 1.4
|
|
Glasgow Outcome Scale-Extended (GOS-E) Peds
3 months
|
4.2 score on a scale
Standard Deviation 2.4
|
3.8 score on a scale
Standard Deviation 2.3
|
4.6 score on a scale
Standard Deviation 1.3
|
|
Glasgow Outcome Scale-Extended (GOS-E) Peds
6 months
|
4.3 score on a scale
Standard Deviation 2.3
|
3.7 score on a scale
Standard Deviation 2.6
|
2.9 score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 1 week, 1 month, 3 months, and 6 monthsTest of working memory; higher scores represent a better outcome, range from 0 to infinity
Outcome measures
| Measure |
Placebo
n=12 Participants
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.
|
Tranexamic Acid Dose A
n=9 Participants
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.
|
Tranexamic Acid Dose B
n=10 Participants
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.
|
|---|---|---|---|
|
Digit Span Recall Test
Total forward digit span, 1 week
|
8.8 score on a scale
Standard Deviation 2.8
|
8.4 score on a scale
Standard Deviation 1.7
|
8.4 score on a scale
Standard Deviation 4.3
|
|
Digit Span Recall Test
Total forward digit span, 1 month
|
7.5 score on a scale
Standard Deviation 2.6
|
7.2 score on a scale
Standard Deviation 1.9
|
7.9 score on a scale
Standard Deviation 3.7
|
|
Digit Span Recall Test
Total backward digit span, 1 month
|
5.3 score on a scale
Standard Deviation 2.6
|
6.2 score on a scale
Standard Deviation 1.8
|
6.2 score on a scale
Standard Deviation 1.3
|
|
Digit Span Recall Test
Total backward digit span, 1 week
|
7.3 score on a scale
Standard Deviation 1.0
|
6.0 score on a scale
Standard Deviation 1.6
|
6.0 score on a scale
Standard Deviation 3.3
|
|
Digit Span Recall Test
Total forward digit span, 3 months
|
8.6 score on a scale
Standard Deviation 2.5
|
9.1 score on a scale
Standard Deviation 3.6
|
10.4 score on a scale
Standard Deviation 1.5
|
|
Digit Span Recall Test
Total backward digit span, 3 months
|
6.5 score on a scale
Standard Deviation 1.1
|
8.7 score on a scale
Standard Deviation 3.6
|
7.8 score on a scale
Standard Deviation 0.8
|
|
Digit Span Recall Test
Total forward digit span, 6 months
|
8.4 score on a scale
Standard Deviation 2.3
|
11.7 score on a scale
Standard Deviation 3.9
|
10.0 score on a scale
Standard Deviation 2.4
|
|
Digit Span Recall Test
Total backward digit span, 6 months
|
5.8 score on a scale
Standard Deviation 2.9
|
10.4 score on a scale
Standard Deviation 4.1
|
6.0 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: First 48 hours after randomizationPopulation: Torso and Both groups
Total volume of packed red blood cells, platelets, fresh frozen plasma, and cryoprecipitate
Outcome measures
| Measure |
Placebo
n=5 Participants
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.
|
Tranexamic Acid Dose A
n=5 Participants
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.
|
Tranexamic Acid Dose B
n=5 Participants
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.
|
|---|---|---|---|
|
Blood Transfusion
|
303.6 ml
Standard Deviation 571.9
|
367.4 ml
Standard Deviation 821.5
|
150.4 ml
Standard Deviation 214.1
|
SECONDARY outcome
Timeframe: 24 hours (±6 hours)Population: Brain Injury and Both groups
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.
Outcome measures
| Measure |
Placebo
n=7 Participants
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.
|
Tranexamic Acid Dose A
n=4 Participants
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.
|
Tranexamic Acid Dose B
n=4 Participants
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.
|
|---|---|---|---|
|
Intracranial Hemorrhage Progression
|
0.003 Proportional change
Standard Deviation 0.013
|
0.003 Proportional change
Standard Deviation 0.004
|
0.001 Proportional change
Standard Deviation 0.001
|
SECONDARY outcome
Timeframe: Day 7 of hospitalization or hospital discharge (whichever comes first)Any non-cerebral venous or arterial thrombosis on standard diagnostic imaging post-randomization
Outcome measures
| Measure |
Placebo
n=12 Participants
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.
|
Tranexamic Acid Dose A
n=9 Participants
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.
|
Tranexamic Acid Dose B
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Any Non-cerebral Venous or Arterial Thrombosis
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 hours after receiving drugClinical or electroencephalogram-documented
Outcome measures
| Measure |
Placebo
n=12 Participants
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.
|
Tranexamic Acid Dose A
n=9 Participants
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.
|
Tranexamic Acid Dose B
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Seizures
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and completion of 8 hour infusionPopulation: Data were not collected
Changes in coagulation biomarkers due to study intervention
Outcome measures
Outcome data not reported
Adverse Events
Tranexamic Acid Dose A
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Tranexamic Acid Dose B
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tranexamic Acid Dose A
n=9 participants at risk
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.
|
Tranexamic Acid Dose B
n=10 participants at risk
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.
|
Placebo
n=12 participants at risk
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.
|
|---|---|---|---|
|
Nervous system disorders
Seizure
|
0.00%
0/9 • 6 months
Adverse Events were monitored/assessed without regard to the specific Adverse Event; defined as any untoward medical occurrence experienced by a subject; may constitute a disease, a set of related signs or symptoms, or a single sign or symptom
|
0.00%
0/10 • 6 months
Adverse Events were monitored/assessed without regard to the specific Adverse Event; defined as any untoward medical occurrence experienced by a subject; may constitute a disease, a set of related signs or symptoms, or a single sign or symptom
|
8.3%
1/12 • 6 months
Adverse Events were monitored/assessed without regard to the specific Adverse Event; defined as any untoward medical occurrence experienced by a subject; may constitute a disease, a set of related signs or symptoms, or a single sign or symptom
|
Other adverse events
| Measure |
Tranexamic Acid Dose A
n=9 participants at risk
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.
|
Tranexamic Acid Dose B
n=10 participants at risk
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.
|
Placebo
n=12 participants at risk
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.
|
|---|---|---|---|
|
General disorders
Adverse Event
|
100.0%
9/9 • 6 months
Adverse Events were monitored/assessed without regard to the specific Adverse Event; defined as any untoward medical occurrence experienced by a subject; may constitute a disease, a set of related signs or symptoms, or a single sign or symptom
|
100.0%
10/10 • 6 months
Adverse Events were monitored/assessed without regard to the specific Adverse Event; defined as any untoward medical occurrence experienced by a subject; may constitute a disease, a set of related signs or symptoms, or a single sign or symptom
|
83.3%
10/12 • 6 months
Adverse Events were monitored/assessed without regard to the specific Adverse Event; defined as any untoward medical occurrence experienced by a subject; may constitute a disease, a set of related signs or symptoms, or a single sign or symptom
|
Additional Information
Daniel Nishijima, Study Co-PI
University of California, Davis
Phone: 916.734.3884
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place