The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery (TXA-OMFS)

August 2, 2021 updated by: Nick Emanuele

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B4A 3W5
        • Nova Scotia Health Authority

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention TXA
patients receiving TXA10mg/kg IV pre-operatively
Drug: 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
Placebo Comparator: Placebo
patients will receive an equivalent amount of normal saline 0.9% IV pre-operatively
Other: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nick Emanuele

Investigators

  • Principal Investigator: Nick Emanuele, DDS, BBA, Nova Scotia Health Authority

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

July 6, 2020

Study Registration Dates

First Submitted

February 8, 2018

First Submitted That Met QC Criteria

February 13, 2018

First Posted (Actual)

February 14, 2018

Study Record Updates

Last Update Posted (Actual)

August 6, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1023246

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data will be used for internal use only

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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