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This study has been withdrawn prior to enrollment.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

April 30, 2008
September 2, 2010
October 2008
June 2009   (final data collection date for primary outcome measure)
Intraoperative bleeding amount [ Time Frame: During the surgery ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00671281 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Effect of Tranexamic Acid on Intraoperative and Post-Operative Bleeding in Functional Endoscopic Sinus Surgery
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Sinusitis
  • 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
  • Drug: Placebo
    Placebo, Oral form, three times a day, 3 days before/day of/6 days after surgery
  • 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.
    Intervention: Drug: Tranexamic acid
  • 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).
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
74
December 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00671281
Tranexamic Acid in FESS
No
Dr. Brad Mechor, Division of Otolaryngology, University of Calgary
University of Calgary
Not Provided
Principal Investigator: Brad D Mechor, MD Division of Otolaryngology, University of Calgary
University of Calgary
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP