The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2020-07-06

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.

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Detailed Description

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Conditions

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Tranexamic Acid Orthognathic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

The patient will be unaware of which group they have been randomized into

Study Groups

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Intervention TXA

patients receiving TXA10mg/kg IV pre-operatively

Group Type EXPERIMENTAL

Tranexamic Acid Injectable Solution

Intervention Type DRUG

the drug will be given to patients intravenously at a dose of 10mg/kg pre-operatively after induction on general anesthesia

Placebo

patients will receive an equivalent amount of normal saline 0.9% IV pre-operatively

Group Type PLACEBO_COMPARATOR

Placebo (normal saline 0.9%)

Intervention Type OTHER

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.

Interventions

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Tranexamic Acid Injectable Solution

the drug will be given to patients intravenously at a dose of 10mg/kg pre-operatively after induction on general anesthesia

Intervention Type DRUG

Placebo (normal saline 0.9%)

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.

Intervention Type OTHER

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

Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes