NCT00671281

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Sinusitis

Interventions

Type	Name	Description
DRUG	Tranexamic acid	Oral form, 100mg, tid (three times per day), 3 days before/the day of/6 days after the surgery
DRUG	Placebo	Placebo, Oral form, three times a day, 3 days before/day of/6 days after surgery

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-06-01
• Completion: 2009-12-01
• First posted: 2008-05-05
• Last updated: 2010-09-03

Locations

1 site across 1 country: Canada