Hypotension During SurgeryPhase 4NCT05474027
Reducing Hypotensive Anesthesia Use With TXA During Orthognathic Surgery
A Phase 4 study testing Avoidance of Deliberate Hypotensive Anesthesia and TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION in people with Hypotension During Surgery and Blood Loss, Surgical, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypotension During Surgery, Blood Loss, Surgical
- What is being tested?
- Avoidance of Deliberate Hypotensive Anesthesia and TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2022to 1 Dec 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Bimaxillary orthognathic surgery completed at UAB Highlands Hospital
Who cannot join
- History of hypertension or previously diagnosed cardiac problems
- Bleeding diathesis
- TXA medically contraindicated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Tranexamic Acid Reduce the Need for Deliberate Hypotensive Anesthesia Within Orthognathic Surgery? A Prospective Study
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.
Read the detailed description
Our goal is to enroll 50 patients. Patients will be recruited from Dr. Kinard's regularly scheduled orthognathic cases at UAB Highlands Hospital. The patient will be informed of the study in advance and have consent signed pre-operatively. Patients will be evaluated for the following variables: sex, age, weight at time of surgery, preoperative hemoglobin, and preoperative hematocrit. Patients will be included if they are undergoing bimaxillary orthognathic surgery at UAB Highlands Hospital. All patients treated with orthognathic surgery already are provided 1g of TXA perioperatively and this will be continued through this study. All patients will be treated with 1g of TXA perioperatively and the anesthesia team will be instructed to limit deliberate hypotensive anesthesia unless otherwise directed by the surgeon. Perioperative and post-operative measurements will include: estimated blood loss, pre and post-operative hemoglobin, pre and post-operative hematocrit, average mean arterial pressure throughout the case (MAP), maximum MAP (excluding induction and emergence), minimum MAP (excluding induction and emergence), total MAP time under 65 mmHg, length of procedure, and surgeon evaluation of visual field throughout the procedure utilizing Fromme's ordinal scale. Based on these factors, it will help determine the need for deliberate hypotensive anesthesia during orthognathic surgery when tranexamic acid is administered.
- Conditions
- Hypotension During Surgery, Blood Loss, Surgical
- Being tested
- Avoidance of Deliberate Hypotensive Anesthesia, TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION
- Keywords
- orthognathic surgery
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients Receiving Tranexamic Acid with Avoidance of Hypotensive Anesthesia | Experimental | Not described Receives: Other: Avoidance of Deliberate Hypotensive Anesthesia; Drug: TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgeon's Analysis of Surgical Field Visualization
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).
Measured: through surgical procedure, and average of 2 hours
Percentage of Hours to Maintain a Mean Arterial Pressure
Tracking mean arterial pressures throughout surgery, evaluating if patient's blood pressure can be reliably kept around patient's baseline instead of deliberate hypotensive anesthesia.
Measured: through surgical procedure, and average of 2 hours
Average Volume of Blood Loss on a Scale
Volume 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.
Measured: through surgical procedure, and average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start11 Nov 2022
- Primary completion11 Nov 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypotension During SurgeryStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Our goal is to enroll 50 patients. Patients will be recruited from Dr. Kinard's regularly scheduled orthognathic cases at UAB Highlands Hospital. The patient will be informed of the study in advance and have consent signed pre-operatively. 1g of tranexamic acid will be given perioperatively as already routinely performed. The anesthesia team will be asked to avoid deliberate hypotensive anesthesia and maintain blood pressure closer to patient baseline.
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Kinard, University of Alabama at Birmingham
- Investigators
- Brian Kinard, DMD, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474027
- Sponsor's protocol ID
- IRB-300009440
- Other IDs
- UAB
- Status last verified
- Dec 2025
- First submitted
- 20 Jul 2022
- Last updated
- 27 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weber TM Jr, Squier B, Kinard BE. Is Tranexamic Acid Associated With a Reduced Need for Hypotensive Anesthesia During Orthognathic Surgery? J Oral Maxillofac Surg. 2025 Dec;83(12):1470-1477. doi: 10.1016/j.joms.2025.08.013. Epub 2025 Sep 4.
PubMed 40975121
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Tranexamic Acid Reduce the Need for Deliberate Hypotensive Anesthesia Within Orthognathic Surgery? A Prospective Study
- ClinicalTrials.gov ID
- NCT05474027
- Acronym / sponsor ID
- IRB-300009440
- Conditions
- Hypotension During Surgery, Blood Loss, Surgical
- Keywords
- orthognathic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 11 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 26 Jul 2022 (actual)
- Results
- Posted 27 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Our goal is to enroll 50 patients. Patients will be recruited from Dr. Kinard's regularly scheduled orthognathic cases at UAB Highlands Hospital. The patient will be informed of the study in advance and have consent signed pre-operatively. Patients will be evaluated for the following variables: sex, age, weight at time of surgery, preoperative hemoglobin, and preoperative hematocrit. Patients will be included if they are undergoing bimaxillary orthognathic surgery at UAB Highlands Hospital. All patients treated with orthognathic surgery already are provided 1g of TXA perioperatively and this will be continued through this study. All patients will be treated with 1g of TXA perioperatively and the anesthesia team will be instructed to limit deliberate hypotensive anesthesia unless otherwise directed by the surgeon. Perioperative and post-operative measurements will include: estimated blood loss, pre and post-operative hemoglobin, pre and post-operative hematocrit, average mean arterial pressure throughout the case (MAP), maximum MAP (excluding induction and emergence), minimum MAP (excluding induction and emergence), total MAP time under 65 mmHg, length of procedure, and surgeon evaluation of visual field throughout the procedure utilizing Fromme's ordinal scale. Based on these factors, it will help determine the need for deliberate hypotensive anesthesia during orthognathic surgery when tranexamic acid is administered.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Our goal is to enroll 50 patients. Patients will be recruited from Dr. Kinard's regularly scheduled orthognathic cases at UAB Highlands Hospital. The patient will be informed of the study in advance and have consent signed pre-operatively. 1g of tranexamic acid will be given perioperatively as already routinely performed. The anesthesia team will be asked to avoid deliberate hypotensive anesthesia and maintain blood pressure closer to patient baseline.
| Arm | Type | Receives |
|---|---|---|
| Patients Receiving Tranexamic Acid with Avoidance of Hypotensive Anesthesia | Experimental | Other: Avoidance of Deliberate Hypotensive Anesthesia, Drug: TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Bimaxillary orthognathic surgery completed at UAB Highlands Hospital
Key exclusion criteria (3 listed)
- History of hypertension or previously diagnosed cardiac problems
- Bleeding diathesis
- TXA medically contraindicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avoidance of Deliberate Hypotensive AnesthesiaThe anesthesia team will be asked to avoid deliberate hypotensive anesthesia and maintain blood pressure closer to the patient's baseline throughout the surgery. | Other | Patients Receiving Tranexamic Acid with Avoidance of Hypotensive Anesthesia |
| TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION1g of tranexamic acid will be given intravenously to patient undergoing orthognathic surgery as routinely performed about 5-15 minutes before first surgical incision. | Drug | Patients Receiving Tranexamic Acid with Avoidance of Hypotensive Anesthesia |
Primary outcome
Surgeon's Analysis of Surgical Field Visualization
Time frame: through surgical procedure, and average of 2 hours
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).
Percentage of Hours to Maintain a Mean Arterial Pressure
Time frame: through surgical procedure, and average of 2 hours
Tracking mean arterial pressures throughout surgery, evaluating if patient's blood pressure can be reliably kept around patient's baseline instead of deliberate hypotensive anesthesia.
Average Volume of Blood Loss on a Scale
Time frame: through surgical procedure, and average of 2 hours
Volume 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40975121Weber TM Jr, Squier B, Kinard BE. Is Tranexamic Acid Associated With a Reduced Need for Hypotensive Anesthesia During Orthognathic Surgery? J Oral Maxillofac Surg. 2025 Dec;83(12):1470-1477. doi: 10.1016/j.joms.2025.08.013. Epub 2025 Sep 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Kinard, DMD, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Avoidance of Deliberate Hypotensive Anesthesia and TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION in people with Hypotension During Surgery and Blood Loss, Surgical, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgeon's Analysis of Surgical Field Visualization (time frame: through surgical procedure, and average of 2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05474027, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.