Chronic Sinusitis Clinical Trial
Official title:
Effect of Tranexamic Acid on Postoperative Bleeding Following Sinus and Nasal Surgery
Verified date | March 2023 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
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
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 |
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