CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 115 enrolled
Drug / intervention
TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION +1 moredrug
Likely dose
TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTIONfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05474027
NCT05474027Phase 4Completed

Does Tranexamic Acid Reduce the Need for Deliberate Hypotensive Anesthesia Within Orthognathic Surgery? A Prospective Study

University of Alabama at Birmingham·interventional·Posted Jul 26, 2022·Updated May 27, 2026

In Brief

A Phase 4 clinical trial evaluating Avoidance of Deliberate Hypotensive Anesthesia and TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION for Hypotension During Surgery and Blood Loss, Surgical. Completed, enrolled 115 participants across 1 site.

Detailed Summary

This prospective study will analyze the need for deliberate hypotensive anesthesia (DHA) during orthognathic surgery when tranexamic acid (TXA) is administered. DHA has been proven to be effective although it comes with multiple risks related to organ hypoperfusion including kidney injury, stroke, and cardiac ischemia. Therefore, it may be potentially safer for patients to avoid deliberate hypotensive anesthesia if TXA alone adequately controls blood loss and provides adequate surgical site visualization.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedJul 26, 2022
Enrollment StartNov 11, 2022
Primary CompletionNov 11, 2025
Study CompletionDec 1, 2025
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 3.9 years ago

Interventions

Avoidance of Deliberate Hypotensive Anesthesiaother

The anesthesia team will be asked to avoid deliberate hypotensive anesthesia and maintain blood pressure closer to the patient's baseline throughout the surgery.

TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTIONdrug

1g of tranexamic acid will be given intravenously to patient undergoing orthognathic surgery as routinely performed about 5-15 minutes before first surgical incision.