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The purpose of the research is to assess the effectiveness of a dose of intravenous tranexamic acid (TXA) given intraoperatively to reduce postoperative bleeding after endoscopic sinus or nasal surgery (e.g. septoplasty, endoscopic sinus surgery, turbinate surgery). This medication has been shown to decrease blood loss during this type of surgery, but the implications for bleeding following surgery are unclear. Any impact on postoperative bleeding will be assessed over the first 7 days following surgery leading up to the first scheduled postoperative clinic visit. Patients will keep a standardized daily diary of their bleeding experience by indicating on a 0-10 visual analog scale (VAS) their impression of their bleeding.
The primary outcome is the patient-reported visual analog scale (VAS) bleeding score on each day after surgery. The secondary outcomes include the the frequency with which the otolaryngology resident service is requested to evaluate patients in the recovery unit for postoperative bleeding concerns and the frequency of interventions such as application of hemostatic materials, packing, cautery, and/or return to the operating room.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1,000mg IV Tranexamic acid | Experimental | Participants in this arm will be given a 1,000mg dose of intravenous tranexamic acid via saline infusion 15 minutes prior to the completion of surgery. They will keep a bleeding diary with daily entries each day until their first routine scheduled postoperative follow-up clinic visit one week after surgery. |
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| Normal saline | No Intervention | Participants in this arm will not be given any extra intervention over their routine anesthetic care. They will continue to receive their normal saline infusion during surgery. They will keep a bleeding diary with daily entries each day until their first routine scheduled postoperative follow-up clinic visit one week after surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid 1,000 Mg/10 mL (100 Mg/mL) INTRAVEN VIAL (ML) | Drug | Medication administered 15 minutes prior to end of surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| Bleeding VAS - POD1 | Patient-reported Visual Analog Scale - Bleeding Score Day 1. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding). | Postoperative Day 1 (assessed within first 24 hours following surgery) |
| Bleeding VAS - POD2 | Patient-reported Visual Analog Scale - Bleeding Score Day 2. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding). | Postoperative Day 2 |
| Bleeding VAS - POD3 | Patient-reported Visual Analog Scale - Bleeding Score Day 3. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding). | Postoperative Day 3 |
| Bleeding VAS - POD4 | Patient-reported Visual Analog Scale - Bleeding Score Day 4. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding). | Postoperative Day 4 |
| Bleeding VAS - POD5 | Patient-reported Visual Analog Scale - Bleeding Score Day 5. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding). | Postoperative Day 5 |
| Bleeding VAS - POD6 | Patient-reported Visual Analog Scale - Bleeding Score Day 6. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding). | Postoperative Day 6 |
| Bleeding VAS - POD7 | Patient-reported Visual Analog Scale - Bleeding Score Day 7. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding). |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Participant Follow-up | Number of patients in each arm requiring evaluation by the resident service for bleeding concerns expressed by the recovery nurse (in PACU), had any follow-up visit or phone call outside of regularly scheduled follow-up | Day of surgery through 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zara M. Patel, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24260760 | Background | Pundir V, Pundir J, Georgalas C, Fokkens WJ. Role of tranexamic acid in endoscopic sinus surgery - a systematic review and meta-analysis. Rhinology. 2013 Dec;51(4):291-7. doi: 10.4193/Rhino13.042. | |
| 31008946 | Background | Ping WD, Zhao QM, Sun HF, Lu HS, Li F. Role of tranexamic acid in nasal surgery: A systemic review and meta-analysis of randomized control trial. Medicine (Baltimore). 2019 Apr;98(16):e15202. doi: 10.1097/MD.0000000000015202. |
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No current plan to share data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Saline | Participants continue to receive their normal saline infusion during surgery. |
| FG001 | 1,000mg IV Tranexamic Acid | 1,000mg dose of intravenous tranexamic acid via saline infusion 15 minutes prior to the completion of surgery. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 10, 2021 |
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| Postoperative Day 7 |
| Guaze Saturation VAS Though POD7 | Patient-reported Visual Analog Scale - Guaze Saturation Score through Postoperative Day 7. Score range: 0 (not at all) to 10 (dripping blood). | Postoperative Day 2 through Postoperative Day 7 |
| 22137511 | Background | Alimian M, Mohseni M. The effect of intravenous tranexamic acid on blood loss and surgical field quality during endoscopic sinus surgery: a placebo-controlled clinical trial. J Clin Anesth. 2011 Dec;23(8):611-5. doi: 10.1016/j.jclinane.2011.03.004. |
| 30593688 | Background | Kim DH, Kim S, Kang H, Jin HJ, Hwang SH. Efficacy of tranexamic acid on operative bleeding in endoscopic sinus surgery: A meta-analysis and systematic review. Laryngoscope. 2019 Apr;129(4):800-807. doi: 10.1002/lary.27766. Epub 2018 Dec 28. |
| 33522019 | Background | El-Ozairy HSE, Mady OM, Tawfik GM, Elhennawy AM, Teaima AA, Ebied A, Huy NT. Outcomes of combined use of topical and intravenous tranexamic acid on surgical field quality during functional endoscopic sinus surgery: Randomized controlled trial. Head Neck. 2021 May;43(5):1389-1397. doi: 10.1002/hed.26610. Epub 2021 Jan 31. |
| 36608352 | Result | Khanwalkar A, Chan E, Roozdar P, Kim D, Ma Y, Hwang PH, Nayak JV, Patel ZM. Tranexamic acid does not significantly lower postoperative bleeding after endoscopic sinus and nasal surgery. Int Forum Allergy Rhinol. 2023 Sep;13(9):1584-1591. doi: 10.1002/alr.23127. Epub 2023 Feb 6. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Saline | Participants continue to receive their normal saline infusion during surgery. |
| BG001 | 1,000mg IV Tranexamic Acid | 1,000mg dose of intravenous tranexamic acid via saline infusion 15 minutes prior to the completion of surgery. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Bleeding VAS - POD1 | Patient-reported Visual Analog Scale - Bleeding Score Day 1. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding). | Posted | Mean | Standard Deviation | score on a scale | Postoperative Day 1 (assessed within first 24 hours following surgery) |
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| Primary | Bleeding VAS - POD2 | Patient-reported Visual Analog Scale - Bleeding Score Day 2. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding). | Posted | Mean | Standard Deviation | score on a scale | Postoperative Day 2 |
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| Primary | Bleeding VAS - POD3 | Patient-reported Visual Analog Scale - Bleeding Score Day 3. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding). | Posted | Mean | Standard Deviation | score on a scale | Postoperative Day 3 |
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| Primary | Bleeding VAS - POD4 | Patient-reported Visual Analog Scale - Bleeding Score Day 4. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding). | Posted | Mean | Standard Deviation | score on a scale | Postoperative Day 4 |
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| Primary | Bleeding VAS - POD5 | Patient-reported Visual Analog Scale - Bleeding Score Day 5. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding). | Posted | Mean | Standard Deviation | score on a scale | Postoperative Day 5 |
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| Primary | Bleeding VAS - POD6 | Patient-reported Visual Analog Scale - Bleeding Score Day 6. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding). | Posted | Mean | Standard Deviation | score on a scale | Postoperative Day 6 |
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| Primary | Bleeding VAS - POD7 | Patient-reported Visual Analog Scale - Bleeding Score Day 7. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding). | Posted | Mean | Standard Deviation | score on a scale | Postoperative Day 7 |
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| Secondary | Frequency of Participant Follow-up | Number of patients in each arm requiring evaluation by the resident service for bleeding concerns expressed by the recovery nurse (in PACU), had any follow-up visit or phone call outside of regularly scheduled follow-up | Posted | Count of Participants | Participants | Day of surgery through 1 week |
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| Primary | Guaze Saturation VAS Though POD7 | Patient-reported Visual Analog Scale - Guaze Saturation Score through Postoperative Day 7. Score range: 0 (not at all) to 10 (dripping blood). | Posted | Mean | Standard Deviation | score on a scale | Postoperative Day 2 through Postoperative Day 7 |
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Up to 6 months
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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 | Normal Saline | Participants continue to receive their normal saline infusion during surgery. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG001 | 1,000mg IV Tranexamic Acid | 1,000mg dose of intravenous tranexamic acid via saline infusion 15 minutes prior to the completion of surgery. | 0 | 21 | 0 | 21 | 0 | 21 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zara M. Patel, MD | Stanford University | 650-723-5651 | zmpatel@stanford.edu |
| Mar 7, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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