The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery

Conditions
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Tranexamic Acid, Orthognathic Surgery

Intervention / Treatment
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* Drug: Tranexamic Acid Injectable Solution
* Other: Placebo (normal saline 0.9%)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention TXA<br>patients receiving TXA10mg/kg IV pre-operatively | Drug: Tranexamic Acid Injectable Solution<br>* the drug will be given to patients intravenously at a dose of 10mg/kg pre-operatively after induction on general anesthesia<br>|
| Placebo Comparator: Placebo<br>patients will receive an equivalent amount of normal saline 0.9% IV pre-operatively | Other: Placebo (normal saline 0.9%)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss during surgery | meticulous measurement of the total blood loss encountered during surgery | intra-operative only |