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

September 2, 2010 updated by: University of Calgary

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

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 Overview

Status

Withdrawn

Conditions

Study Type

Interventional

Enrollment (Anticipated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alberta
      • Calgary, Alberta, Canada, T2V 1P9
        • Rockyview General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: B
This group will be the experimental group which will receive tranexamic acid in oral form three days before and six days after surgery.
Oral form, 100mg, tid (three times per day), 3 days before/the day of/6 days after the surgery
Other Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraoperative bleeding amount
Time Frame: During the surgery
During the surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Brad D Mechor, MD, Division of Otolaryngology, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Anticipated)

June 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

April 30, 2008

First Submitted That Met QC Criteria

May 4, 2008

First Posted (Estimate)

May 5, 2008

Study Record Updates

Last Update Posted (Estimate)

September 3, 2010

Last Update Submitted That Met QC Criteria

September 2, 2010

Last Verified

September 1, 2010

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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