Phase 4
N=66
The Efficacy and Population Pharmacokinetics of Tranexamic Acid for Craniosynostosis Surgery
Craniosynostosis
Bottom Line
View on ClinicalTrials.gov: NCT02188576 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Efficacy of TXA in Childrens Having Craniosynostosis Surgery — 23.6; 21.3 mL/kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- high dose TXA (Drug); Low dose TXA (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Boston Children's Hospital
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of TXA in Childrens Having Craniosynostosis Surgery |
23.6; 21.3 | — |
| SECONDARY Plasma Levels of TXA in Children Having Craniosynostosis Surgery |
50.2; 29.6 | — |
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 corrective surgery. This surgery is associated with significant blood loss and frequently requires the transfusion of blood. TXA is a medication that reduces the amount of bleeding during surgery by improving clotting of the blood at the surgical site. TXA is an FDA-approved drug that is routinely used in infants and children undergoing major surgery including heart surgery, craniofacial surgery and scoliosis surgery. It has been shown to decrease both the amount of bleeding and the amount of blood transfusion needed. We would like to compare the different doses of TXA to see if a lower dose has the same effect on blood loss as a higher dose. We are also interested to learn why TXA seems to work better in some patients than in others. In order to study the effect of this drug we would like to give this drug to your child and measure the blood loss and the volume of blood given to your child during his/her surgery.
The research is being done at two sites; Boston Children's Hospital and Gaslini Children's Hospital in Genoa, Italy. The main study doctor from Boston Children's Hospital is Dr. Susan Goobie. The Department of Anesthesiology at Boston Children's Hospital is sponsoring this study.
We are planning to study a total of 68 infants and children from age 3 months to 6 years old scheduled for open craniosynostosis surgery at Boston Children's Hospital or Gaslini Children's Hospital.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02188576). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.