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| ID | Type | Description | Link |
|---|---|---|---|
| UAB | Other Identifier | UAB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients Receiving Tranexamic Acid with Avoidance of Hypotensive Anesthesia | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avoidance of Deliberate Hypotensive Anesthesia | Other | The anesthesia team will be asked to avoid deliberate hypotensive anesthesia and maintain blood pressure closer to the patient's baseline throughout the surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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. | through surgical procedure, and average of 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Kinard, DMD, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Hospital-Highlands | Birmingham | Alabama | 35205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40975121 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | score on a scale | through surgical procedure, and average of 2 hours |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Kinard, DMD, MD | University of Alabama at Birmingham | 205-934-5334 | briankinard@uabmc.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 16, 2024 | Apr 22, 2026 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D007275 | Injections, Intravenous |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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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.
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| TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION | Drug | 1g of tranexamic acid will be given intravenously to patient undergoing orthognathic surgery as routinely performed about 5-15 minutes before first surgical incision. |
|
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
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| Primary | 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. | Posted | Mean | Inter-Quartile Range | percentage of hours | through surgical procedure, and average of 2 hours |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | through surgical procedure, and average of 2 hours |
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| 0 |
| 115 |
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| 115 |
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| 115 |
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| D061605 |
| Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007267 | Injections |
| D004364 | Pharmaceutical Preparations |