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

Chronic Sinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04754230
• Other study ID #: IRB-59164
• Status: Completed
• Phase: Phase 4
• Start date: June 17, 2021
• Est. completion date: February 20, 2022

Study information

• Verified date: March 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 20, 2022
• Est. primary completion date: February 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Chronic Sinusitis
• Deviated Nasal Septum - Congenital
• Deviated Nasal Septum Acquired
• Hypertrophy
• Nasal Obstruction
• Postoperative Hemorrhage
• Sinusitis
• Turbinate; Hypertrophy Mucous Membrane

Intervention

Drug:
• Tranexamic Acid 1,000 Mg/10 mL (100 Mg/mL) INTRAVEN VIAL (ML)
Medication administered 15 minutes prior to end of surgery.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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 Jan 6. doi: 10.1002/alr.23127. Online — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Rhinology. 2014 Mar;52(1):77. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Bleeding VAS - POD2	Patient-reported Visual Analog Scale - Bleeding Score Day 2. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).	Postoperative Day 2
Primary	Bleeding VAS - POD3	Patient-reported Visual Analog Scale - Bleeding Score Day 3. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).	Postoperative Day 3
Primary	Bleeding VAS - POD4	Patient-reported Visual Analog Scale - Bleeding Score Day 4. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).	Postoperative Day 4
Primary	Bleeding VAS - POD5	Patient-reported Visual Analog Scale - Bleeding Score Day 5. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).	Postoperative Day 5
Primary	Bleeding VAS - POD6	Patient-reported Visual Analog Scale - Bleeding Score Day 6. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).	Postoperative Day 6
Primary	Bleeding VAS - POD7	Patient-reported Visual Analog Scale - Bleeding Score Day 7. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).	Postoperative Day 7
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).	Postoperative Day 2 through Postoperative Day 7
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	Day of surgery through 1 week