Status:
COMPLETED
The Efficacy and Population Pharmacokinetics of Tranexamic Acid for Craniosynostosis Surgery
Lead Sponsor:
Boston Children's Hospital
Conditions:
Craniosynostosis
Eligibility:
All Genders
3-6 years
Phase:
PHASE4
Brief Summary
This research study is being performed to evaluate two different doses of Tranexamic acid (TXA) in children who have craniosynostosis and have been referred to Boston Children's Hospital for correctiv...
Detailed Description
Introduction: Over 90% of open craniosynostosis surgical procedures are associated with a transfusion of blood or blood products. Goobie et. al. recently showed that tranexamic acid in a dose of 50 mg...
Eligibility Criteria
Inclusion
- Patients (age range 3 months to 6 years) undergoing craniosynostosis repair, fronto-orbital advancement surgery and cranial remodeling surgery (i.e. total cavernal remodeling surgery).
Exclusion
- Preexisting hematological abnormality (defined as a positive history of bleeding disorder or a known diagnosis of a genetic or acquired bleeding disorder)
- Preexisting coagulation defect (defined as PT, PTT or INR \>1.5 times normal or a n pre-existing genetic or acquired coagulation defect))
- Preexisting hepatic, renal, vascular, ocular and/or metabolic disorder
- History of acetylsalicylate ingestion within the last 14 days.
- History of NSAIDs ingestion with 2 days of the scheduled surgery date
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT02188576
Start Date
August 1 2014
End Date
January 1 2018
Last Update
January 31 2020
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115