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

Phase 4

Completed

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

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

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
1,000mg IV Tranexamic acid	Tranexamic Acid 1,000 Mg/10 mL (100 Mg/mL) INTRAVEN VIAL (ML)	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.

Primary Outcome Measures

Name	Time	Method
Bleeding VAS - POD3	Postoperative Day 3	Patient-reported Visual Analog Scale - Bleeding Score Day 3. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Bleeding VAS - POD4	Postoperative Day 4	Patient-reported Visual Analog Scale - Bleeding Score Day 4. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Bleeding VAS - POD5	Postoperative Day 5	Patient-reported Visual Analog Scale - Bleeding Score Day 5. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Bleeding VAS - POD6	Postoperative Day 6	Patient-reported Visual Analog Scale - Bleeding Score Day 6. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Bleeding VAS - POD7	Postoperative Day 7	Patient-reported Visual Analog Scale - Bleeding Score Day 7. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Guaze Saturation VAS Though POD7	Postoperative Day 2 through Postoperative Day 7	Patient-reported Visual Analog Scale - Guaze Saturation Score through Postoperative Day 7. Score range: 0 (not at all) to 10 (dripping blood).
Bleeding VAS - POD2	Postoperative Day 2	Patient-reported Visual Analog Scale - Bleeding Score Day 2. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Bleeding VAS - POD1	Postoperative Day 1 (assessed within first 24 hours following surgery)	Patient-reported Visual Analog Scale - Bleeding Score Day 1. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).

Secondary Outcome Measures

Name	Time	Method
Frequency of Participant Follow-up	Day of surgery through 1 week	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