The Efficacy and Population Pharmacokinetics of Tranexamic Acid for Craniosynostosis Surgery
Condition: Craniosynostosis
MeSH terms: Craniosynostoses
Intervention: high dose TXA; Low dose TXA
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 66.0
Sex: All
Minimum age: 3 Months
Maximum age: 6 Years
Healthy volunteers: No
Keywords: Craniofacial Surgery; tranexamic acid; Antifibrinolytic

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