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

University of Calgary

Status: Withdrawn

Conditions: Chronic Sinusitis

Treatments: Drug: Placebo; Drug: Tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT00671281

Tranexamic Acid in FESS

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 2 patient groups, including a placebo group

B

Experimental group

Description:

This group will be the experimental group which will receive tranexamic acid in oral form three days before and six days after surgery.

Treatment:

Drug: Tranexamic acid

A

Placebo Comparator group

Description:

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).

Treatment:

Drug: Placebo