The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery (TXA-OMFS)

Nick Emanuele

Status and phase: Withdrawn; Phase 4

Conditions: Tranexamic Acid; Orthognathic Surgery

Treatments: Drug: Tranexamic Acid Injectable Solution; Other: Placebo (normal saline 0.9%)

Study type: Interventional

Funder types: Other

Identifiers

NCT03433144

1023246

Details and patient eligibility

About

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.

Sex: All

Ages: 16 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

Intervention TXA

Experimental group

Description:

patients receiving TXA10mg/kg IV pre-operatively

Treatment:

Drug: Tranexamic Acid Injectable Solution

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo (normal saline 0.9%)