Trial Outcomes & Findings for A Pilot Study Comparing Anti-Inflammatory Effects Of TXA Versus EACA In Pediatric Congenital Heart Surgery (NCT NCT02656472)
NCT ID: NCT02656472
Last Updated: 2024-10-24
Results Overview
Consented patients had research-related blood draws (0.3 ml) at three time points: pre-CPB, post-CBP following protamine administration and 24 hours post-CPB. Average of the values run in duplicate was used for calculations. For samples with values reported as out of range (due to level being below detection), the lowest detectable value was assigned for analysis.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
22 participants
Primary outcome timeframe
24 hours post-surgery
Results posted on
2024-10-24
Participant Flow
Dates of recruitment: From February 2016 to September 2016
1 patient excluded after consent, prior to randomization, as exclusion criteria were present prior to surgery. At mid-study analysis, 1 significant outlier was noted (met inclusion criteria but was inpatient at time of randomization with multiple comorbidities where all other subjects were admitted on day of surgery).
Participant milestones
| Measure |
Tranexamic Acid (TXA) Arm
TXA arm will include 10 subjects who will receive TXA for duration of surgery.
Tranexamic acid: TXA Loading dose: 31 mg/kg diluted to 2 ml/kg NS
|
Epsilon Aminocaproic Acid (EACA) Arm
EACA arm will include 10 subjects who will receive EACA for the duration of surgery.
Epsilon Aminocaproic Acid: Aminocaproic acid Loading dose: 75 mg/kg diluted to 2 ml/kg NS.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Tranexamic Acid Arm
n=10 Participants
TXA arm included 10 subjects who received TXA for duration of surgery.
TXA dosing strategy used an initial 31 mg/kg load at start of surgery, followed by 14 mg/kg/hr continuous infusion, and weight-dependent bolus dose after heparinization.
|
Epsilon Aminocaproic Acid Arm
n=10 Participants
EACA arm included 10 subjects who will received EACA for the duration of surgery.
EACA dosing strategy used an initial 75 mg/kg load at start of surgery, followed by 75 mg/kg/hr continuous infusion, and 75 mg/kg bolus dose after heparinization.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.6 years
STANDARD_DEVIATION 4.7 • n=10 Participants
|
11.4 years
STANDARD_DEVIATION 6.0 • n=10 Participants
|
10.5 years
STANDARD_DEVIATION 7.0 • n=20 Participants
|
|
Sex/Gender, Customized
Male
|
6 participants
n=10 Participants
|
6 participants
n=10 Participants
|
12 participants
n=20 Participants
|
|
Sex/Gender, Customized
Female
|
4 participants
n=10 Participants
|
4 participants
n=10 Participants
|
8 participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Weight
|
35.4 Weight (kg)
STANDARD_DEVIATION 19.2 • n=10 Participants
|
11.4 Weight (kg)
STANDARD_DEVIATION 6.0 • n=10 Participants
|
20.5 Weight (kg)
STANDARD_DEVIATION 22.2 • n=20 Participants
|
|
Height
|
136 centimeters
STANDARD_DEVIATION 33.8 • n=10 Participants
|
139 centimeters
STANDARD_DEVIATION 38.0 • n=10 Participants
|
137.5 centimeters
STANDARD_DEVIATION 36.0 • n=20 Participants
|
|
STAT category
|
2.6 units on a scale
STANDARD_DEVIATION 1.0 • n=10 Participants
|
2.4 units on a scale
STANDARD_DEVIATION 0.7 • n=10 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 0.85 • n=20 Participants
|
PRIMARY outcome
Timeframe: 24 hours post-surgeryConsented patients had research-related blood draws (0.3 ml) at three time points: pre-CPB, post-CBP following protamine administration and 24 hours post-CPB. Average of the values run in duplicate was used for calculations. For samples with values reported as out of range (due to level being below detection), the lowest detectable value was assigned for analysis.
Outcome measures
| Measure |
Tranexamic Acid (TXA) Arm
n=10 Participants
TXA dosing strategy used an initial 31 mg/kg load at start of surgery, followed by 14 mg/kg/hr continuous infusion, and weight-dependent bolus dose after heparinization.
|
Epsilon Aminocaproic Acid (EACA) Arm
n=10 Participants
EACA dosing strategy used an initial 75 mg/kg load at start of surgery, followed by 75 mg/kg/hr continuous infusion, and 75 mg/kg bolus dose after heparinization.
|
|---|---|---|
|
Inflammatory Markers/Cytokines
24 hour post MCP-1
|
180.0 pg/dl
Interval 92.3 to 235.0
|
180.2 pg/dl
Interval 9.8 to 221.1
|
|
Inflammatory Markers/Cytokines
Pre-CPB IL-1B
|
1.5 pg/dl
Interval 0.8 to 1.8
|
2.1 pg/dl
Interval 1.4 to 3.5
|
|
Inflammatory Markers/Cytokines
Pre-CPB-IL2
|
1.6 pg/dl
Interval 1.1 to 2.2
|
2.2 pg/dl
Interval 1.4 to 4.3
|
|
Inflammatory Markers/Cytokines
Pre-CPB-IL4
|
0.4 pg/dl
Interval 0.2 to 0.6
|
0.6 pg/dl
Interval 0.2 to 1.1
|
|
Inflammatory Markers/Cytokines
Pre-CPB-IL5
|
0.2 pg/dl
Interval 0.1 to 0.4
|
0.4 pg/dl
Interval 0.2 to 0.9
|
|
Inflammatory Markers/Cytokines
Pre-CPB-IL6
|
0.2 pg/dl
Interval 0.1 to 1.5
|
0.6 pg/dl
Interval 0.2 to 1.1
|
|
Inflammatory Markers/Cytokines
Pre-CPB-IL8
|
3.0 pg/dl
Interval 1.8 to 6.6
|
6.1 pg/dl
Interval 2.2 to 13.1
|
|
Inflammatory Markers/Cytokines
Pre-CPB IL-10Beta
|
3.0 pg/dl
Interval 2.3 to 6.0
|
3.2 pg/dl
Interval 2.2 to 6.5
|
|
Inflammatory Markers/Cytokines
Pre-CPB IL-12
|
0.2 pg/dl
Interval 0.2 to 0.5
|
0.4 pg/dl
Interval 0.2 to 2.6
|
|
Inflammatory Markers/Cytokines
Pre-CPB IL-13
|
0.2 pg/dl
Interval 0.0 to 1.5
|
1.3 pg/dl
Interval 0.0 to 7.8
|
|
Inflammatory Markers/Cytokines
Pre-CPB TNF Alpha
|
16.6 pg/dl
Interval 12.7 to 24.0
|
19.6 pg/dl
Interval 10.9 to 32.5
|
|
Inflammatory Markers/Cytokines
Pre-CPB IFN gamma
|
1.1 pg/dl
Interval 1.1 to 1.8
|
1.0 pg/dl
Interval 0.3 to 3.2
|
|
Inflammatory Markers/Cytokines
Pre-CPB GM-CSF
|
3.6 pg/dl
Interval 2.7 to 6.7
|
5.4 pg/dl
Interval 2.1 to 11.0
|
|
Inflammatory Markers/Cytokines
Pre-CPB MCP-1
|
184.7 pg/dl
Interval 133.0 to 228.6
|
224.6 pg/dl
Interval 170.7 to 323.4
|
|
Inflammatory Markers/Cytokines
Post-CPB IL-1
|
1.5 pg/dl
Interval 1.2 to 1.6
|
2.2 pg/dl
Interval 1.2 to 5.4
|
|
Inflammatory Markers/Cytokines
Post-CPB IL-2
|
2.2 pg/dl
Interval 1.7 to 2.5
|
2.7 pg/dl
Interval 1.5 to 4.1
|
|
Inflammatory Markers/Cytokines
Post-CPB IL-4
|
0.4 pg/dl
Interval 0.2 to 0.6
|
0.6 pg/dl
Interval 0.2 to 3.7
|
|
Inflammatory Markers/Cytokines
Post-CPB IL-5
|
0.1 pg/dl
Interval 0.1 to 0.3
|
0.3 pg/dl
Interval 0.1 to 1.6
|
|
Inflammatory Markers/Cytokines
Post-CPB IL-6
|
43.0 pg/dl
Interval 19.6 to 69.6
|
28.5 pg/dl
Interval 21.9 to 30.9
|
|
Inflammatory Markers/Cytokines
Post-CPB IL-8
|
19.6 pg/dl
Interval 12.3 to 69.7
|
28.0 pg/dl
Interval 11.3 to 57.8
|
|
Inflammatory Markers/Cytokines
Post-CPB IL-10
|
1047.6 pg/dl
Interval 646.4 to 1996.8
|
2338.3 pg/dl
Interval 1995.5 to 2839.3
|
|
Inflammatory Markers/Cytokines
Post-CPB IL-12
|
0.2 pg/dl
Interval 0.2 to 1.9
|
0.9 pg/dl
Interval 0.2 to 3.9
|
|
Inflammatory Markers/Cytokines
Post-CPB IL-13
|
0.2 pg/dl
Interval 0.0 to 0.7
|
1.4 pg/dl
Interval 0.0 to 15.1
|
|
Inflammatory Markers/Cytokines
Post-CPB TNF Alpha
|
15.3 pg/dl
Interval 11.5 to 22.8
|
15.2 pg/dl
Interval 9.6 to 27.6
|
|
Inflammatory Markers/Cytokines
Post-CPB IFN Gamma
|
1.1 pg/dl
Interval 0.1 to 2.1
|
0.9 pg/dl
Interval 0.1 to 2.7
|
|
Inflammatory Markers/Cytokines
Post-CPB GM-CSF
|
5.8 pg/dl
Interval 3.9 to 8.4
|
7.3 pg/dl
Interval 5.3 to 13.0
|
|
Inflammatory Markers/Cytokines
Post-CPB MCP-1
|
308.6 pg/dl
Interval 256.4 to 507.9
|
251.9 pg/dl
Interval 218.6 to 385.5
|
|
Inflammatory Markers/Cytokines
24 hour post CPB IL-1
|
1.2 pg/dl
Interval 0.9 to 1.8
|
1.0 pg/dl
Interval 1.0 to 2.6
|
|
Inflammatory Markers/Cytokines
24 hour post CPB IL-2
|
1.3 pg/dl
Interval 0.9 to 2.2
|
1.4 pg/dl
Interval 0.8 to 3.4
|
|
Inflammatory Markers/Cytokines
24 hour post CPB IL-4
|
0.6 pg/dl
Interval 0.2 to 0.6
|
0.6 pg/dl
Interval 0.2 to 0.8
|
|
Inflammatory Markers/Cytokines
24 hour post CPB IL-5
|
0.1 pg/dl
Interval 0.0 to 0.5
|
0.0 pg/dl
Interval 0.0 to 0.6
|
|
Inflammatory Markers/Cytokines
24 hour post CPB IL-6
|
14.7 pg/dl
Interval 8.3 to 44.0
|
28.0 pg/dl
Interval 10.8 to 39.6
|
|
Inflammatory Markers/Cytokines
24 hour post CPB IL-8
|
7.5 pg/dl
Interval 5.1 to 39.7
|
10.9 pg/dl
Interval 9.1 to 21.8
|
|
Inflammatory Markers/Cytokines
24 hour post CPB IL-10
|
6.2 pg/dl
Interval 4.5 to 33.3
|
13.3 pg/dl
Interval 5.5 to 27.2
|
|
Inflammatory Markers/Cytokines
24 hour post CPB IL-12
|
0.2 pg/dl
Interval 0.2 to 0.4
|
0.2 pg/dl
Interval 0.2 to 2.8
|
|
Inflammatory Markers/Cytokines
24 hour post CPB IL-13
|
0.1 pg/dl
Interval 0.0 to 0.9
|
0.6 pg/dl
Interval 0.0 to 5.7
|
|
Inflammatory Markers/Cytokines
24 hour post CPB TNF Alpha
|
10.8 pg/dl
Interval 8.3 to 16.1
|
13.2 pg/dl
Interval 8.1 to 16.3
|
|
Inflammatory Markers/Cytokines
24 hour post CPB IFN Gamma
|
0.6 pg/dl
Interval 0.3 to 0.6
|
1.0 pg/dl
Interval 0.3 to 2.3
|
|
Inflammatory Markers/Cytokines
24 hour post CPB GM-CSF
|
5.1 pg/dl
Interval 3.1 to 8.8
|
5.1 pg/dl
Interval 1.6 to 9.5
|
SECONDARY outcome
Timeframe: 48 hours post-surgeryChest tube output in ml/kg for the first 48 hours
Outcome measures
| Measure |
Tranexamic Acid (TXA) Arm
n=10 Participants
TXA dosing strategy used an initial 31 mg/kg load at start of surgery, followed by 14 mg/kg/hr continuous infusion, and weight-dependent bolus dose after heparinization.
|
Epsilon Aminocaproic Acid (EACA) Arm
n=10 Participants
EACA dosing strategy used an initial 75 mg/kg load at start of surgery, followed by 75 mg/kg/hr continuous infusion, and 75 mg/kg bolus dose after heparinization.
|
|---|---|---|
|
Chest Tube Output
|
5.1 ml/kg
Interval 3.7 to 18.4
|
7.8 ml/kg
Interval 6.1 to 16.7
|
SECONDARY outcome
Timeframe: 48 hours post-surgeryCompare the volume of blood product replacement needed in first 48 hours of surgery (including blood products used in OR)
Outcome measures
| Measure |
Tranexamic Acid (TXA) Arm
n=10 Participants
TXA dosing strategy used an initial 31 mg/kg load at start of surgery, followed by 14 mg/kg/hr continuous infusion, and weight-dependent bolus dose after heparinization.
|
Epsilon Aminocaproic Acid (EACA) Arm
n=10 Participants
EACA dosing strategy used an initial 75 mg/kg load at start of surgery, followed by 75 mg/kg/hr continuous infusion, and 75 mg/kg bolus dose after heparinization.
|
|---|---|---|
|
Blood Replacement Volume
pRBC
|
0.0 ml/kg
Interval 0.0 to 8.7
|
0.0 ml/kg
Interval 0.0 to 12.7
|
|
Blood Replacement Volume
Platelets
|
2.0 ml/kg
Interval 0.0 to 7.5
|
1.4 ml/kg
Interval 0.0 to 8.3
|
|
Blood Replacement Volume
FFP
|
0.0 ml/kg
Interval 0.0 to 4.7
|
0.0 ml/kg
Interval 0.0 to 5.6
|
SECONDARY outcome
Timeframe: Immediately post-surgery and 24 hours post-surgeryAntifibrinolytic effect using platelets levels x 1000/mL
Outcome measures
| Measure |
Tranexamic Acid (TXA) Arm
n=10 Participants
TXA dosing strategy used an initial 31 mg/kg load at start of surgery, followed by 14 mg/kg/hr continuous infusion, and weight-dependent bolus dose after heparinization.
|
Epsilon Aminocaproic Acid (EACA) Arm
n=10 Participants
EACA dosing strategy used an initial 75 mg/kg load at start of surgery, followed by 75 mg/kg/hr continuous infusion, and 75 mg/kg bolus dose after heparinization.
|
|---|---|---|
|
Platelet Levels
Platelet Day 0
|
163.7 Platelets x1000/mL
Standard Deviation 58.2
|
185.1 Platelets x1000/mL
Standard Deviation 54.5
|
|
Platelet Levels
Platelet Day 1
|
124.8 Platelets x1000/mL
Standard Deviation 47.8
|
162.8 Platelets x1000/mL
Standard Deviation 49.4
|
SECONDARY outcome
Timeframe: Immediately post-surgery and 24 hours post-surgeryTests were recorded and compared between the groups to analyze the effect of the antifibrinolytic agent used on the amount of blood loss as well as effect of inflammation on the liver and kidney.
Outcome measures
| Measure |
Tranexamic Acid (TXA) Arm
n=10 Participants
TXA dosing strategy used an initial 31 mg/kg load at start of surgery, followed by 14 mg/kg/hr continuous infusion, and weight-dependent bolus dose after heparinization.
|
Epsilon Aminocaproic Acid (EACA) Arm
n=10 Participants
EACA dosing strategy used an initial 75 mg/kg load at start of surgery, followed by 75 mg/kg/hr continuous infusion, and 75 mg/kg bolus dose after heparinization.
|
|---|---|---|
|
Liver Enzymes
AST Day 0
|
131.8 U/L
Standard Deviation 130.8
|
119.3 U/L
Standard Deviation 162.4
|
|
Liver Enzymes
AST Day 1
|
254.8 U/L
Standard Deviation 307.8
|
175.1 U/L
Standard Deviation 225.7
|
|
Liver Enzymes
ALT Day 0
|
36.6 U/L
Standard Deviation 24.2
|
74.5 U/L
Standard Deviation 122.3
|
|
Liver Enzymes
ALT Day 1
|
29.7 U/L
Standard Deviation 13.9
|
31.4 U/L
Standard Deviation 14.5
|
SECONDARY outcome
Timeframe: Immediately post-surgery and 24 hours post-surgeryTests were recorded and compared between the groups to analyze the effect of the antifibrinolytic agent used on the amount of blood loss as well as effect of inflammation on the liver and kidney.
Outcome measures
| Measure |
Tranexamic Acid (TXA) Arm
n=10 Participants
TXA dosing strategy used an initial 31 mg/kg load at start of surgery, followed by 14 mg/kg/hr continuous infusion, and weight-dependent bolus dose after heparinization.
|
Epsilon Aminocaproic Acid (EACA) Arm
n=10 Participants
EACA dosing strategy used an initial 75 mg/kg load at start of surgery, followed by 75 mg/kg/hr continuous infusion, and 75 mg/kg bolus dose after heparinization.
|
|---|---|---|
|
Hemoglobin
Hemoglobin Day 0
|
10.2 g/dl
Standard Deviation 1.7
|
11.1 g/dl
Standard Deviation 1.8
|
|
Hemoglobin
Hemoglobin Day 1
|
10.3 g/dl
Standard Deviation 1.3
|
9.9 g/dl
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Immediately post-surgery and 24 hours post-surgeryTests were recorded and compared between the groups to analyze the effect of the antifibrinolytic agent used on the amount of blood loss as well as effect of inflammation on the liver and kidney.
Outcome measures
| Measure |
Tranexamic Acid (TXA) Arm
n=10 Participants
TXA dosing strategy used an initial 31 mg/kg load at start of surgery, followed by 14 mg/kg/hr continuous infusion, and weight-dependent bolus dose after heparinization.
|
Epsilon Aminocaproic Acid (EACA) Arm
n=10 Participants
EACA dosing strategy used an initial 75 mg/kg load at start of surgery, followed by 75 mg/kg/hr continuous infusion, and 75 mg/kg bolus dose after heparinization.
|
|---|---|---|
|
Creatinine
creatinine Day 0
|
0.6 mg/dl
Standard Deviation 0.2
|
0.6 mg/dl
Standard Deviation 0.2
|
|
Creatinine
creatinine Day 1
|
0.5 mg/dl
Standard Deviation 0.1
|
0.7 mg/dl
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: 2 monthsLength of stay in the ICU and overall hospital stay.
Outcome measures
| Measure |
Tranexamic Acid (TXA) Arm
n=10 Participants
TXA dosing strategy used an initial 31 mg/kg load at start of surgery, followed by 14 mg/kg/hr continuous infusion, and weight-dependent bolus dose after heparinization.
|
Epsilon Aminocaproic Acid (EACA) Arm
n=10 Participants
EACA dosing strategy used an initial 75 mg/kg load at start of surgery, followed by 75 mg/kg/hr continuous infusion, and 75 mg/kg bolus dose after heparinization.
|
|---|---|---|
|
Length of Stay
ICU length of stay
|
4.0 days
Interval 2.0 to 5.5
|
2.0 days
Interval 1.8 to 4.0
|
|
Length of Stay
Hospital length of stay
|
4.0 days
Interval 2.0 to 5.8
|
3.5 days
Interval 2.0 to 12.5
|
Adverse Events
Tranexamic Acid Arm
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Epsilon Aminocaproic Acid Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tranexamic Acid Arm
n=10 participants at risk
TXA arm will include 10 subjects who will receive TXA for duration of surgery.
Tranexamic acid: TXA Loading dose: 31 mg/kg diluted to 2 ml/kg NS.
|
Epsilon Aminocaproic Acid Arm
n=10 participants at risk
EACA arm will include 10 subjects who will receive EACA for the duration of surgery.
Epsilon Aminocaproic Acid: Aminocaproic acid Loading dose: 75 mg/kg diluted to 2 ml/kg NS.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrage
|
10.0%
1/10 • Number of events 1 • 9 months
|
0.00%
0/10 • 9 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place