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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This study has been withdrawn prior to enrollment.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:
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00671281
First received: April 30, 2008
Last updated: September 2, 2010
Last verified: September 2010
History of Changes
  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
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

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy Sinusitis
U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Intraoperative bleeding amount [ Time Frame: During the surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: April 30, 2008
Last Updated: September 2, 2010
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on May 16, 2013