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Completed

NCT Number: NCT04754230

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

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.

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Key information

Conditions

Chronic Sinusitis Airway Obstruction Deviated Nasal Septum - Congenital Deviated Nasal Septum Acquired Nasal Obstruction Nose Diseases Otorhinolaryngologic Diseases Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Turbinate; Hypertrophy Mucous Membrane

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stanford University

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Medication administered 15 minutes prior to end of surgery.

Primary outcomes

  1. Bleeding VAS - POD1

    Time frame: Postoperative Day 1 (assessed within first 24 hours following surgery)

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

  2. Bleeding VAS - POD2

    Time frame: Postoperative Day 2

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

  3. Bleeding VAS - POD3

    Time frame: Postoperative Day 3

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

  4. Bleeding VAS - POD4

    Time frame: Postoperative Day 4

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

  5. Bleeding VAS - POD5

    Time frame: Postoperative Day 5

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

  6. Bleeding VAS - POD6

    Time frame: Postoperative Day 6

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

  7. Bleeding VAS - POD7

    Time frame: Postoperative Day 7

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

  8. Guaze Saturation VAS Though POD7

    Time frame: Postoperative Day 2 through Postoperative Day 7

    Patient-reported Visual Analog Scale - Guaze Saturation Score through Postoperative Day 7. Score range: 0 (not at all) to 10 (dripping blood).

Secondary outcomes

  1. Frequency of Participant Follow-up

    Time frame: Day of surgery through 1 week

    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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 15, 2021
Registry last updated
Apr 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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