Trial Outcomes & Findings for Reducing Hypotensive Anesthesia Use With TXA During Orthognathic Surgery (NCT NCT05474027)
NCT ID: NCT05474027
Last Updated: 2026-05-27
Results Overview
The surgeon will evaluate surgical field visibility using Fromme's ordinal scale. Fromme's ordinal scale (often referred to as the Fromme-Boezaart scale) is a 5-point, 0-5 visual grading system used by surgeons to assess the quality of the surgical field, primarily based on bleeding and suction frequency. It measures surgical conditions from 0 (no bleeding, perfectly dry) to 5 (severe bleeding, flooding the field).
COMPLETED
PHASE4
115 participants
through surgical procedure, and average of 2 hours
2026-05-27
Participant Flow
Participant milestones
| Measure |
Patients Receiving Tranexamic Acid With Avoidance of Hypotensive Anesthesia
Avoidance of Deliberate Hypotensive Anesthesia: 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, SOLUTION: 1g of tranexamic acid will be given intravenously to patient undergoing orthognathic surgery as routinely performed about 5-15 minutes before first surgical incision.
|
|---|---|
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Overall Study
STARTED
|
115
|
|
Overall Study
COMPLETED
|
115
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reducing Hypotensive Anesthesia Use With TXA During Orthognathic Surgery
Baseline characteristics by cohort
| Measure |
Patients Receiving Tranexamic Acid With Avoidance of Hypotensive Anesthesia
n=115 Participants
Avoidance of Deliberate Hypotensive Anesthesia: 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, SOLUTION: 1g of tranexamic acid will be given intravenously to patient undergoing orthognathic surgery as routinely performed about 5-15 minutes before first surgical incision.
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|---|---|
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Race (NIH/OMB)
White
|
90 Participants
n=51 Participants
|
|
Age, Categorical
<=18 years
|
17 Participants
n=51 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
97 Participants
n=51 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=51 Participants
|
|
Age, Continuous
|
26 years
n=51 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
115 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=51 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
|
Region of Enrollment
United States
|
115 Participants
n=51 Participants
|
PRIMARY outcome
Timeframe: through surgical procedure, and average of 2 hoursThe surgeon will evaluate surgical field visibility using Fromme's ordinal scale. Fromme's ordinal scale (often referred to as the Fromme-Boezaart scale) is a 5-point, 0-5 visual grading system used by surgeons to assess the quality of the surgical field, primarily based on bleeding and suction frequency. It measures surgical conditions from 0 (no bleeding, perfectly dry) to 5 (severe bleeding, flooding the field).
Outcome measures
| Measure |
Patients Receiving Tranexamic Acid With Avoidance of Hypotensive Anesthesia
n=115 Participants
Avoidance of Deliberate Hypotensive Anesthesia: 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, SOLUTION: 1g of tranexamic acid will be given intravenously to patient undergoing orthognathic surgery as routinely performed about 5-15 minutes before first surgical incision.
|
|---|---|
|
Surgeon's Analysis of Surgical Field Visualization
|
1.3 score on a scale
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: through surgical procedure, and average of 2 hoursTracking mean arterial pressures throughout surgery, evaluating if patient's blood pressure can be reliably kept around patient's baseline instead of deliberate hypotensive anesthesia.
Outcome measures
| Measure |
Patients Receiving Tranexamic Acid With Avoidance of Hypotensive Anesthesia
n=115 Participants
Avoidance of Deliberate Hypotensive Anesthesia: 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, SOLUTION: 1g of tranexamic acid will be given intravenously to patient undergoing orthognathic surgery as routinely performed about 5-15 minutes before first surgical incision.
|
|---|---|
|
Percentage of Hours to Maintain a Mean Arterial Pressure
|
14.3 percentage of hours
Interval 2.0 to 34.0
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PRIMARY outcome
Timeframe: through surgical procedure, and average of 2 hoursVolume of blood loss recorded during surgical case based on the Fromme's scale. Fromme's ordinal scale (often referred to as the Fromme-Boezaart scale) is a 5-point, 0-5 visual grading system used by surgeons to assess the quality of the surgical field, primarily based on bleeding and suction frequency. It measures surgical conditions from 0 (no bleeding, perfectly dry) to 5 (severe bleeding, flooding the field), widely applied in orthognathic, sinus, and spine surgeries to evaluate the effectiveness of techniques like hypotensive anesthesia.
Outcome measures
| Measure |
Patients Receiving Tranexamic Acid With Avoidance of Hypotensive Anesthesia
n=115 Participants
Avoidance of Deliberate Hypotensive Anesthesia: 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, SOLUTION: 1g of tranexamic acid will be given intravenously to patient undergoing orthognathic surgery as routinely performed about 5-15 minutes before first surgical incision.
|
|---|---|
|
Average Volume of Blood Loss on a Scale
|
1.3 score on a scale
Standard Deviation 0.5
|
Adverse Events
Patients Receiving Tranexamic Acid With Avoidance of Hypotensive Anesthesia
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brian Kinard, DMD, MD
University of Alabama at Birmingham
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place