Clinical trial NCT00671281: The Effect of Tranexamic Acid on Intraoperative and Post-Operative Bleeding in Functional Endoscopic Sinus Surgery
Official title: The Effect of Tranexamic Acid on Intraoperative and Post-Operative Bleeding in Functional Endoscopic Sinus Surgery: A Randomized, Prospective, Double-Blinded Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Sinusitis
Keywords: FESS
Tranexamic acid
Hemostasis
Visualization
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2008-05-05
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Intraoperative bleeding amount
timeFrame: During the surgery
Secondary outcomes:
measure: Surgical visualization scoring
timeFrame: During the surgery
measure: Postoperative bleeding events
timeFrame: Six days after the surgery
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Rockyview General Hospital
state: Alberta
Study officials:
affiliation: Division of Otolaryngology, University of Calgary
name: Brad D Mechor, MD
role: PRINCIPAL_INVESTIGATOR
References:
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