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

NCT00671281 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2010-09-03

No results posted yet for this study

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.

Conditions

  • Chronic Sinusitis

Interventions

DRUG

Tranexamic acid

Oral form, 100mg, tid (three times per day), 3 days before/the day of/6 days after the surgery

DRUG

Placebo

Placebo, Oral form, three times a day, 3 days before/day of/6 days after surgery

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Brad D Mechor, MD · Division of Otolaryngology, University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-06-30
Completion
2009-12-31

Countries

  • Canada

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00671281 on ClinicalTrials.gov