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

Stanford University

Status and phase: Completed; Phase 4

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04754230

IRB-59164

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

1,000mg IV Tranexamic acid

Experimental group

Description:

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.

Treatment:

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

Normal saline

No Intervention group

Description:

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.