Trial Outcomes & Findings for The Efficacy and Population Pharmacokinetics of Tranexamic Acid for Craniosynostosis Surgery (NCT NCT02188576)
NCT ID: NCT02188576
Last Updated: 2020-01-31
Results Overview
Determine the efficacy ( as measured by blood loss and blood transfusion) of TXA in infants and children undergoing open craniofacial surgery with this lower dosage scheme.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
66 participants
Primary outcome timeframe
perioperatively from the intraoperative period to 24 hours postoperatively
Results posted on
2020-01-31
Participant Flow
The recruitment locations were the preoperative clinics at Boston Children's Hospital (Boston, MA) and Gaslini Children's Hospital (Genoa, Italy) from 2014 to 2017.
Participant milestones
| Measure |
High Dose TXA
High dose TXA is the intervention.
A higher dose of tranexamic acid will be given to this arm as follows:
50 mg/kg loading dose and 5 mg/kg/h infusion
high dose TXA
|
Low Dose TXA
Low dose TXA is the intervention.
A lower dose of TXa will be given as follows:
10 mg/kg loading dose and 5 mg/kg/h infusion
Low dose TXA
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
34
|
|
Overall Study
COMPLETED
|
32
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Efficacy and Population Pharmacokinetics of Tranexamic Acid for Craniosynostosis Surgery
Baseline characteristics by cohort
| Measure |
High Dose TXA
n=32 Participants
High dose TXA is the intervention.
A higher dose of tranexamic acid will be given to this arm as follows:
50 mg/kg loading dose and 5 mg/kg/h infusion
high dose TXA
|
Low Dose TXA
n=34 Participants
Low dose TXA is the intervention.
A lower dose of TXa will be given as follows:
10 mg/kg loading dose and 5 mg/kg/h infusion
Low dose TXA
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
8 months
n=5 Participants
|
8.5 months
n=7 Participants
|
8.25 months
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: perioperatively from the intraoperative period to 24 hours postoperativelyPopulation: To determine if a tranexamic acid dose regimen of 10 mg/kg loading dose and 5 mg/kg/h maintenance dose is as effective as a higher dose regime of 50 mg/kg loading dose and 5 mg/kg/h maintenance infusion rate in reducing blood transfusion volume in pediatric craniosynostosis reconstruction surgery.
Determine the efficacy ( as measured by blood loss and blood transfusion) of TXA in infants and children undergoing open craniofacial surgery with this lower dosage scheme.
Outcome measures
| Measure |
High Dose TXA
n=32 Participants
High dose TXA is the intervention.
A higher dose of tranexamic acid will be given to this arm as follows:
50 mg/kg loading dose and 5 mg/kg/h infusion
high dose TXA
Outcome: A tranexamic acid dose regimen of 10 mg/kg loading dose and 5 mg/kg/h maintenance dose is as effective as a higher dose regime of 50 mg/kg loading dose and 5 mg/kg/h maintenance infusion rate in reducing blood loss and transfusion requirements in pediatric craniosynostosis reconstruction surgery.
|
Low Dose TXA
n=34 Participants
Low dose TXA is the intervention.
A lower dose of TXa will be given as follows:
10 mg/kg loading dose and 5 mg/kg/h infusion
Low dose TXA
Outcome: A tranexamic acid dose regimen of 10 mg/kg loading dose and 5 mg/kg/h maintenance dose is as effective as a higher dose regime of 50 mg/kg loading dose and 5 mg/kg/h maintenance infusion rate in reducing blood loss and transfusion requirements in pediatric craniosynostosis reconstruction surgery.
|
|---|---|---|
|
Efficacy of TXA in Childrens Having Craniosynostosis Surgery
|
23.6 mL/kg
Standard Error 1.5
|
21.3 mL/kg
Standard Error 1.6
|
SECONDARY outcome
Timeframe: up to 24h postoperativelyDetermine the plasma levels (in micrograms/mL) of TXA in infants and children undergoing open craniofacial surgery with this dosage scheme
Outcome measures
| Measure |
High Dose TXA
n=32 Participants
High dose TXA is the intervention.
A higher dose of tranexamic acid will be given to this arm as follows:
50 mg/kg loading dose and 5 mg/kg/h infusion
high dose TXA
Outcome: A tranexamic acid dose regimen of 10 mg/kg loading dose and 5 mg/kg/h maintenance dose is as effective as a higher dose regime of 50 mg/kg loading dose and 5 mg/kg/h maintenance infusion rate in reducing blood loss and transfusion requirements in pediatric craniosynostosis reconstruction surgery.
|
Low Dose TXA
n=34 Participants
Low dose TXA is the intervention.
A lower dose of TXa will be given as follows:
10 mg/kg loading dose and 5 mg/kg/h infusion
Low dose TXA
Outcome: A tranexamic acid dose regimen of 10 mg/kg loading dose and 5 mg/kg/h maintenance dose is as effective as a higher dose regime of 50 mg/kg loading dose and 5 mg/kg/h maintenance infusion rate in reducing blood loss and transfusion requirements in pediatric craniosynostosis reconstruction surgery.
|
|---|---|---|
|
Plasma Levels of TXA in Children Having Craniosynostosis Surgery
|
50.2 ug/mL
Standard Error 8.0
|
29.6 ug/mL
Standard Error 7.6
|
Adverse Events
High Dose TXA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Dose TXA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place