Clinical trial NCT04754230: Effect of Tranexamic Acid on Postoperative Bleeding Following Sinus and Nasal Surgery
Official title: Effect of Tranexamic Acid on Postoperative Bleeding Following Sinus and Nasal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Sinusitis
Nasal Obstruction
Turbinate; Hypertrophy Mucous Membrane
Deviated Nasal Septum - Congenital
Deviated Nasal Septum Acquired
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Bleeding VAS - POD1
timeFrame: Postoperative Day 1 (assessed within first 24 hours following surgery)
measure: Bleeding VAS - POD2
timeFrame: Postoperative Day 2
measure: Bleeding VAS - POD3
timeFrame: Postoperative Day 3
measure: Bleeding VAS - POD4
timeFrame: Postoperative Day 4
measure: Bleeding VAS - POD5
timeFrame: Postoperative Day 5
measure: Bleeding VAS - POD6
timeFrame: Postoperative Day 6
measure: Bleeding VAS - POD7
timeFrame: Postoperative Day 7
measure: Guaze Saturation VAS Though POD7
timeFrame: Postoperative Day 2 through Postoperative Day 7
Secondary outcomes:
measure: Frequency of Participant Follow-up
timeFrame: Day of surgery through 1 week
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Zara M. Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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.
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 Sep;13(9):1584-1591. doi: 10.1002/alr.23127. Epub 2023 Feb 6.