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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-17

Study Completion Date

2022-02-20

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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1,000mg IV Tranexamic acid

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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Medication administered 15 minutes prior to end of surgery.

Normal saline

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Medication administered 15 minutes prior to end of surgery.

Intervention Type DRUG

Eligibility Criteria

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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

* Enrollment is in conflict with existing study participation

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No