Effect of Tranexamic Acid on Postoperative Bleeding Following Sinus and Nasal Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Tranexamic Acid on Postoperative Bleeding Following Sinus and Nasal Surgery

Conditions
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Chronic Sinusitis, Nasal Obstruction, Turbinate; Hypertrophy Mucous Membrane, Deviated Nasal Septum - Congenital, Deviated Nasal Septum Acquired

Intervention / Treatment
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* Drug: Tranexamic Acid 1,000 Mg/10 mL (100 Mg/mL) INTRAVEN VIAL (ML)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled to undergo elective sinus or nasal surgery (e.g. septoplasty, inferior turbinate reduction, endoscopic sinus surgery) Age 18 or greater English-speaking Able to provide consent Exclusion Criteria: Minors (age<18) Pregnant or may become pregnant by time of surgery Prisoners Non-English speaking Foreign citizens Unable to provide consent Known pro-thrombotic coagulation disorders Active intranasal drug use (e.g. cocaine) Surgery is for a sinonasal tumor or other sinus pathology not described in inclusion criteria Enrollment is in conflict with existing study participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1,000mg IV Tranexamic acid<br>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. | Drug: Tranexamic Acid 1,000 Mg/10 mL (100 Mg/mL) INTRAVEN VIAL (ML)<br>* Medication administered 15 minutes prior to end of surgery.<br>|
| No Intervention: Normal saline<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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). | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |