The Effect of Tranexamic Acid on Intraoperative and Post-Operative Bleeding in Functional Endoscopic Sinus Surgery
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||The Effect of Tranexamic Acid on Intraoperative and Post-Operative Bleeding in Functional Endoscopic Sinus Surgery: A Randomized, Prospective, Double-Blinded Study|
- Intraoperative bleeding amount [ Time Frame: During the surgery ] [ Designated as safety issue: Yes ]
- Surgical visualization scoring [ Time Frame: During the surgery ] [ Designated as safety issue: Yes ]
- Postoperative bleeding events [ Time Frame: Six days after the surgery ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2008|
|Estimated Study Completion Date:||December 2009|
|Estimated Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
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
Oral form, 100mg, tid (three times per day), 3 days before/the day of/6 days after the surgery
Other Name: Cyclokapron
Placebo Comparator: A
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).
Placebo, Oral form, three times a day, 3 days before/day of/6 days after surgery
|Rockyview General Hospital|
|Calgary, Alberta, Canada, T2V 1P9|
|Principal Investigator:||Brad D Mechor, MD||Division of Otolaryngology, University of Calgary|