Chronic Sinusitis Clinical Trial
Official title:
The Effect of Tranexamic Acid on Intraoperative and Post-Operative Bleeding in Functional Endoscopic Sinus Surgery: A Randomized, Prospective, Double-Blinded Study
Verified date | September 2010 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 74 |
Est. completion date | December 2009 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Rockyview General Hospital | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary |
Canada,
Blumenfeld RJ, Skolnik EM. Intracranial complications of sinus disease. Trans Am Acad Ophthalmol Otolaryngol. 1966 Nov-Dec;70(6):899-908. — View Citation
Casati V, Sandrelli L, Speziali G, Calori G, Grasso MA, Spagnolo S. Hemostatic effects of tranexamic acid in elective thoracic aortic surgery: a prospective, randomized, double-blind, placebo-controlled study. J Thorac Cardiovasc Surg. 2002 Jun;123(6):1084-91. — View Citation
Clayman GL, Adams GL, Paugh DR, Koopmann CF Jr. Intracranial complications of paranasal sinusitis: a combined institutional review. Laryngoscope. 1991 Mar;101(3):234-9. — View Citation
Cumberworth VL, Sudderick RM, Mackay IS. Major complications of functional endoscopic sinus surgery. Clin Otolaryngol Allied Sci. 1994 Jun;19(3):248-53. — View Citation
Dunn CJ, Goa KL. Tranexamic acid: a review of its use in surgery and other indications. Drugs. 1999 Jun;57(6):1005-32. Review. — View Citation
Fremes SE, Wong BI, Lee E, Mai R, Christakis GT, McLean RF, Goldman BS, Naylor CD. Metaanalysis of prophylactic drug treatment in the prevention of postoperative bleeding. Ann Thorac Surg. 1994 Dec;58(6):1580-8. — View Citation
Goldwyn RM. Unexpected bleeding after elective nasal surgery. Ann Plast Surg. 1979 Mar;2(3):201-4. — View Citation
Morgan PR, Morrison WV. Complications of frontal and ethmoid sinusitis. Laryngoscope. 1980 Apr;90(4):661-6. — View Citation
Osguthorpe JD. Surgical outcomes in rhinosinusitis: what we know. Otolaryngol Head Neck Surg. 1999 Apr;120(4):451-3. — View Citation
Wormald PJ, van Renen G, Perks J, Jones JA, Langton-Hewer CD. The effect of the total intravenous anesthesia compared with inhalational anesthesia on the surgical field during endoscopic sinus surgery. Am J Rhinol. 2005 Sep-Oct;19(5):514-20. — View Citation
Yaniv E, Shvero J, Hadar T. Hemostatic effect of tranexamic acid in elective nasal surgery. Am J Rhinol. 2006 Mar-Apr;20(2):227-9. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraoperative bleeding amount | During the surgery | Yes | |
Secondary | Surgical visualization scoring | During the surgery | Yes | |
Secondary | Postoperative bleeding events | Six days after the surgery | Yes |
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