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

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00671281
• Other study ID #: Tranexamic Acid in FESS
• Status: Withdrawn
• Phase: N/A
• First received: April 30, 2008
• Last updated: September 2, 2010
• Start date: October 2008
• Est. completion date: December 2009

Study information

• Verified date: September 2010
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Sinusitis
• Postoperative Hemorrhage

Intervention

Drug:
• Tranexamic acid
Oral form, 100mg, tid (three times per day), 3 days before/the day of/6 days after the surgery
• Placebo
Placebo, Oral form, three times a day, 3 days before/day of/6 days after surgery

Locations

Country	Name	City	State
Canada	Rockyview General Hospital	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

References & Publications (11)

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

Outcome

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