We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been withdrawn prior to enrollment.
(Study was cancelled)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00671281
First Posted: May 5, 2008
Last Update Posted: September 3, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Calgary
  Purpose
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.

Condition Intervention
Chronic Sinusitis Drug: Tranexamic acid Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Intraoperative bleeding amount [ Time Frame: During the surgery ]

Secondary Outcome Measures:
  • Surgical visualization scoring [ Time Frame: During the surgery ]
  • Postoperative bleeding events [ Time Frame: Six days after the surgery ]

Estimated Enrollment: 74
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)
Arms Assigned Interventions
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.
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).
Drug: Placebo
Placebo, Oral form, three times a day, 3 days before/day of/6 days after surgery

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00671281


Locations
Canada, Alberta
Rockyview General Hospital
Calgary, Alberta, Canada, T2V 1P9
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: Brad D Mechor, MD Division of Otolaryngology, University of Calgary
  More Information

Publications:

Responsible Party: Dr. Brad Mechor, Division of Otolaryngology, University of Calgary
ClinicalTrials.gov Identifier: NCT00671281     History of Changes
Other Study ID Numbers: Tranexamic Acid in FESS
First Submitted: April 30, 2008
First Posted: May 5, 2008
Last Update Posted: September 3, 2010
Last Verified: September 2010

Keywords provided by University of Calgary:
FESS
Tranexamic acid
Hemostasis
Visualization

Additional relevant MeSH terms:
Sinusitis
Postoperative Hemorrhage
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Hemorrhage
Pathologic Processes
Postoperative Complications
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants