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

Stanford University40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Chronic Sinusitis Nasal Obstruction

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Bleeding VAS - POD1

Patient-reported Visual Analog Scale - Bleeding Score Day 1. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).

Time frame: 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).

Time frame: Postoperative Day 2

Bleeding VAS - POD3

Patient-reported Visual Analog Scale - Bleeding Score Day 3. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).

Time frame: Postoperative Day 3

Bleeding VAS - POD4

Patient-reported Visual Analog Scale - Bleeding Score Day 4. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).

Time frame: Postoperative Day 4

Bleeding VAS - POD5

Patient-reported Visual Analog Scale - Bleeding Score Day 5. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).

Time frame: Postoperative Day 5

Bleeding VAS - POD6

Patient-reported Visual Analog Scale - Bleeding Score Day 6. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).

Time frame: Postoperative Day 6

Bleeding VAS - POD7

Patient-reported Visual Analog Scale - Bleeding Score Day 7. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).

Time frame: 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).

Time frame: Postoperative Day 2 through Postoperative Day 7

Secondary Outcomes

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

Time frame: Day of surgery through 1 week