Tranexamic Acid Clinical Trial
— TXA-OMFSOfficial title:
The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery
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Status | Withdrawn |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 |
Verified date | August 2021 |
Source | Nova Scotia Health Authority |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
Canada | Nova Scotia Health Authority | Halifax | Nova Scotia |
Lead Sponsor | Collaborator |
---|---|
Nick Emanuele |
Canada,
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 |
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