Craniosynostosis Clinical Trial
Official title:
The Efficacy and Population Pharmacokinetics/ Pharmacogenomics of a Reduced Dose of Tranexamic Acid for Craniosynostosis Surgery
NCT number | NCT02188576 |
Other study ID # | P00008434 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | August 2014 |
Est. completion date | January 2018 |
Verified date | January 2020 |
Source | Boston Children’s Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | January 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Months to 6 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Boston Children's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Children’s Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of TXA in Childrens Having Craniosynostosis 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. | perioperatively from the intraoperative period to 24 hours postoperatively | |
Secondary | Plasma Levels of TXA in Children Having Craniosynostosis Surgery | Determine the plasma levels (in micrograms/mL) of TXA in infants and children undergoing open craniofacial surgery with this dosage scheme | up to 24h postoperatively |
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