The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery

Phase 4

Withdrawn

• Conditions: Orthognathic Surgery; Tranexamic Acid
• Interventions: Drug: Tranexamic Acid Injectable Solution; Other: Placebo (normal saline 0.9%)

• Registration Number: NCT03433144
• Lead Sponsor: Nick Emanuele

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-08
• Study First Submitted QC: 2018-02-13
• Study First Posted: 2018-02-14
• Study Start: 2018-06-01
• Primary Completion: 2019-02-01
• Study Completion: 2020-07-06
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention TXA	Tranexamic Acid Injectable Solution	patients receiving TXA10mg/kg IV pre-operatively
Placebo	Placebo (normal saline 0.9%)	patients will receive an equivalent amount of normal saline 0.9% IV pre-operatively

Primary Outcome Measures

Name	Time	Method
blood loss during surgery	intra-operative only	meticulous measurement of the total blood loss encountered during surgery

Trial Locations

Locations (1)

Nova Scotia Health Authority; 🇨🇦 Halifax, Nova Scotia, Canada