The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery

NCT03433144 | Withdrawn Phase 4

• 1 other identifier: 1023246
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Tranexamic Acid; Orthognathic Surgery

Outcome Measures

Primary Outcomes (1)

• blood loss during surgery

  meticulous measurement of the total blood loss encountered during surgery

  intra-operative only

Study Arms (2)

Intervention TXA

EXPERIMENTAL

patients receiving TXA10mg/kg IV pre-operatively

Drug: Tranexamic Acid Injectable Solution

Placebo

PLACEBO COMPARATOR

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

Other: Placebo (normal saline 0.9%)

Interventions

Tranexamic Acid Injectable Solution DRUG

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

Intervention TXA

Placebo (normal saline 0.9%) 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.

Placebo

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nick Emanuele: lead

Study Sites (1)

Nova Scotia Health Authority

Halifax, Nova Scotia, B4A 3W5, Canada

Location

Study Officials

• Nick Emanuele, DDS, BBA

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient will be unaware of which group they have been randomized into
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident, Oral and Maxillofacial Surgery

Model Details: 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.

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 14, 2018
• Study Start: June 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: July 6, 2020
• Last Updated: August 6, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)