Tranexamic Acid, Orthognathic Surgery
Conditions
Brief summary
This study seeks to answer the question: Does a single pre-operative dose of tranexamic acid have a statistically significant reduction in blood loss during orthognathic surgery? If it does, this drug may begin to be used routinely during orthognathic surgery to reduce blood loss in our patients.
Interventions
the drug will be given to patients intravenously at a dose of 10mg/kg pre-operatively after induction on general anesthesia
An equivalent amount of normal saline (0.9%) will be given to the patient pre-operatively after induction of general anesthesia. The amount of saline given will correspond to the same amount of fluid which would have been given had the patient been in the intervention group.
Sponsors
Nick Emanuele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The patient will be unaware of which group they have been randomized into
Intervention model description
In this study, patients will be randomized into two groups: and intervention group and placebo. The intervention group will receive a single pre-operative dose of TXA IV (10mg/kg) and the placebo group will receive the same volume of fluid intravenously.
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients undergoing either * Bilateral saggital split osteotomy (lower jaw surgery) * Lefort 1 osteotomy (upper jaw surgery) * Combination of BSSO and Lefort * Patients between with ages of 16-65 * No cardiac comorbidities (hypertension, congenital heart malformation) * No known coagulopathy * No regular prescription medication altering normal blood coagulation (NSAIDs, other anticoagulants) * ASA I and II patients
Exclusion criteria
* Patients younger than 16 and older than 40 * Patients with known coagulopathy * Patients with cardiac comorbidities * Patients with a family history of bleeding disorders * Patients who have undergone previous orthognathic surgery * ASA III patients or higher
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| blood loss during surgery | intra-operative only | meticulous measurement of the total blood loss encountered during surgery |
Countries
Canada
Outcome results
None listed