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

NCT04754230 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB-59164
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (8)

• 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)

• Bleeding VAS - POD2

  Patient-reported Visual Analog Scale - Bleeding Score Day 2. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).

  Postoperative Day 2

• Bleeding VAS - POD3

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

  Postoperative Day 3

• Bleeding VAS - POD4

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

  Postoperative Day 4

• Bleeding VAS - POD5

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

  Postoperative Day 5

• Bleeding VAS - POD6

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

  Postoperative Day 6

• Bleeding VAS - POD7

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

  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).

  Postoperative Day 2 through Postoperative Day 7

Secondary Outcomes (1)

• Frequency of Participant Follow-up

  Day of surgery through 1 week

Study Arms (2)

1,000mg IV Tranexamic acid

EXPERIMENTAL

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.

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

Normal saline

NO INTERVENTION

Participants in this arm will not be given any extra intervention over their routine anesthetic care. They will continue to receive their normal saline infusion during 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.

Interventions

Tranexamic Acid 1,000 Mg/10 mL (100 Mg/mL) INTRAVEN VIAL (ML) DRUG

Medication administered 15 minutes prior to end of surgery.

1,000mg IV Tranexamic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Enrollment is in conflict with existing study participation

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (6)

• 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.

  PMID: 24260760 BACKGROUND

• 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.

  PMID: 31008946 BACKGROUND

• 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.

  PMID: 22137511 BACKGROUND

• 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.

  PMID: 30593688 BACKGROUND

• 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.

  PMID: 33522019 BACKGROUND

• 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.

  PMID: 36608352 RESULT

MeSH Terms

Conditions

Nasal Obstruction

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Zara M. Patel, MD
• Organization: Stanford University

zmpatel@stanford.edu

650-723-5651

Study Officials

• Zara M. Patel, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 15, 2021
• Study Start: June 17, 2021
• Primary Completion: February 20, 2022
• Study Completion: February 20, 2022
• Last Updated: April 5, 2023
• Results First Posted: April 5, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)