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

Not Applicable

Withdrawn

• Conditions: Chronic Sinusitis
• Interventions: Drug: Placebo; Drug: Tranexamic acid

• Registration Number: NCT00671281
• Lead Sponsor: University of Calgary

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-04-30
• Study First Submitted QC: 2008-05-04
• Study First Posted: 2008-05-05
• Study Start: 2008-10
• Primary Completion: 2009-06
• Study Completion: 2009-12
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-02
• Last Update Posted: 2010-09-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Placebo	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).
B	Tranexamic acid	This group will be the experimental group which will receive tranexamic acid in oral form three days before and six days after surgery.

Primary Outcome Measures

Name	Time	Method
Intraoperative bleeding amount	During the surgery

Secondary Outcome Measures

Name	Time	Method
Surgical visualization scoring	During the surgery
Postoperative bleeding events	Six days after the surgery

Trial Locations

Locations (1)

Rockyview General Hospital; 🇨🇦 Calgary, Alberta, Canada