The Effect of Tranexamic Acid on Intraoperative and Post-Operative Bleeding in Functional Endoscopic Sinus Surgery

Study Overview
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Brief Summary
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Sinus surgery is a common, day surgery procedure performed by general and subspecialty trained otolaryngologists. In most cases, this is a safe surgery with a low incidence of complications. When there is significant bleeding or enough bleeding to obscure important anatomical landmarks, there is a higher chance of complications. These complications can include blindness, meningitis or cerebrospinal fluid leak. Our hypothesis is that in patients taking oral tranexamic acid three days before surgery and six days after, there will be less intraoperative bleeding, better surgical visualization and less postoperative bleeding events.

Official Title
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The Effect of Tranexamic Acid on Intraoperative and Post-Operative Bleeding in Functional Endoscopic Sinus Surgery: A Randomized, Prospective, Double-Blinded Study

Conditions
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Chronic Sinusitis

Intervention / Treatment
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* Drug: Tranexamic acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic sinusitis requiring bilateral functional endoscopic sinus surgery Between the ages of 18-65 Willing to comply with standard followup No coagulopathy Not pregnant Exclusion Criteria: Pregnant On anticoagulants within 3 months of the surgery Coagulopathy <18 or >65 years of age

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B<br>This group will be the experimental group which will receive tranexamic acid in oral form three days before and six days after surgery. | Drug: Tranexamic acid<br>* Oral form, 100mg, tid (three times per day), 3 days before/the day of/6 days after the surgery<br>* Other names: Cyclokapron;|
| Placebo Comparator: A<br>This will be the control group which will take the placebo medication for 3 days before and six days after their functional endoscopic sinus surgery (FESS). | Drug: Placebo<br>* Placebo, Oral form, three times a day, 3 days before/day of/6 days after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative bleeding amount |  | During the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical visualization scoring |  | During the surgery | 
| Postoperative bleeding events |  | Six days after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FESS, Tranexamic acid, Hemostasis, Visualization