Back to resultsThe Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery (TXA-OMFS)
Primary Purpose
Tranexamic Acid, Orthognathic Surgery
Status
Withdrawn
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Tranexamic Acid Injectable Solution
Placebo (normal saline 0.9%)
Sponsored by
About this trial
This is an interventional treatment trial for Tranexamic Acid
Eligibility Criteria
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
Sites / Locations
- Nova Scotia Health Authority
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention TXA
Placebo
Arm Description
patients receiving TXA10mg/kg IV pre-operatively
patients will receive an equivalent amount of normal saline 0.9% IV pre-operatively
Outcomes
Primary Outcome Measures
blood loss during surgery
meticulous measurement of the total blood loss encountered during surgery
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03433144
Brief Title
The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery
Acronym
TXA-OMFS
Official Title
The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
July 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nick Emanuele
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tranexamic Acid, Orthognathic Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
The patient will be unaware of which group they have been randomized into
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention TXA
Arm Type
Experimental
Arm Description
patients receiving TXA10mg/kg IV pre-operatively
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
patients will receive an equivalent amount of normal saline 0.9% IV pre-operatively
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid Injectable Solution
Intervention Description
the drug will be given to patients intravenously at a dose of 10mg/kg pre-operatively after induction on general anesthesia
Intervention Type
Other
Intervention Name(s)
Placebo (normal saline 0.9%)
Intervention Description
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.
Primary Outcome Measure Information:
Title
blood loss during surgery
Description
meticulous measurement of the total blood loss encountered during surgery
Time Frame
intra-operative only
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nick Emanuele, DDS, BBA
Organizational Affiliation
Nova Scotia Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nova Scotia Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B4A 3W5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data will be used for internal use only
Learn more about this trial
The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery
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