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NCT03433144 Clinical Trial

The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery

Tranexamic Acid Clinical Trial

— TXA-OMFS  

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03433144
Other study ID # 1023246
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date June 1, 2018
Est. completion date July 6, 2020

Study information
Verified date August 2021
Source Nova Scotia Health Authority
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date July 6, 2020
Est. primary completion date February 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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
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.

Locations
Country Name City State
Canada Nova Scotia Health Authority Halifax Nova Scotia

Sponsors (1)
Lead Sponsor Collaborator
Nick Emanuele

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary blood loss during surgery meticulous measurement of the total blood loss encountered during surgery intra-operative only
See also
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