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The Efficacy and Population Pharmacokinetics of Tranexamic Acid for Craniosynostosis Surgery

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ClinicalTrials.gov Identifier: NCT02188576
Recruitment Status : Completed
First Posted : July 11, 2014
Results First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Susan Goobie, Boston Children's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Craniosynostosis
Interventions Drug: high dose TXA
Drug: Low dose TXA
Enrollment 66
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title High Dose TXA Low Dose TXA
Hide Arm/Group Description

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 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

Period Title: Overall Study
Started 32 34
Completed 32 34
Not Completed 0 0
Arm/Group Title High Dose TXA Low Dose TXA Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 32 34 66
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 34 participants 66 participants
<=18 years
32
 100.0%
34
 100.0%
66
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Inter-Quartile Range)
Unit of measure:  Months
Number Analyzed 32 participants 34 participants 66 participants
8
(4 to 13.5)
8.5
(5 to 16)
8.25
(4 to 16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 34 participants 66 participants
Female
13
  40.6%
13
  38.2%
26
  39.4%
Male
19
  59.4%
21
  61.8%
40
  60.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 34 participants 66 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
32
 100.0%
34
 100.0%
66
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants 34 participants 66 participants
United States 12 14 26
Italy 20 20 40
1.Primary Outcome
Title Efficacy of TXA in Childrens Having Craniosynostosis Surgery
Hide Description 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.
Time Frame perioperatively from the intraoperative period to 24 hours postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title High Dose TXA Low Dose TXA
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 32 34
Mean (Standard Error)
Unit of Measure: mL/kg
23.6  (1.5) 21.3  (1.6)
2.Secondary Outcome
Title Plasma Levels of TXA in Children Having Craniosynostosis Surgery
Hide Description Determine the plasma levels (in micrograms/mL) of TXA in infants and children undergoing open craniofacial surgery with this dosage scheme
Time Frame up to 24h postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose TXA Low Dose TXA
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 32 34
Mean (Standard Error)
Unit of Measure: ug/mL
50.2  (8.0) 29.6  (7.6)
Time Frame while the patient was in hospital which was up to a maximum of 15 days
Adverse Event Reporting Description side effects including VTE, seizures
 
Arm/Group Title High Dose TXA Low Dose TXA
Hide Arm/Group Description

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 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

All-Cause Mortality
High Dose TXA Low Dose TXA
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/34 (0.00%) 
Hide Serious Adverse Events
High Dose TXA Low Dose TXA
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/34 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
High Dose TXA Low Dose TXA
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/34 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Susan Goobie, PI
Organization: Boston Childrens Hospital
Phone: 6173557737
EMail: susan.goobie@childrens.harvard.edu
Layout table for additonal information
Responsible Party: Susan Goobie, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT02188576    
Other Study ID Numbers: P00008434
First Submitted: July 10, 2014
First Posted: July 11, 2014
Results First Submitted: November 20, 2019
Results First Posted: January 31, 2020
Last Update Posted: January 31, 2020