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

Purpose

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.

Condition	Intervention
Chronic Sinusitis	Drug: Tranexamic acid Drug: Placebo

MedlinePlus related topics:

Endoscopy Sinusitis

ChemIDplus related topics:

Tranexamic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	The Effect of Tranexamic Acid on Intraoperative and Post-Operative Bleeding in Functional Endoscopic Sinus Surgery: A Randomized, Prospective, Double-Blinded Study

Further study details as provided by University of Calgary:

Primary Outcome Measures:

Intraoperative bleeding amount [ Time Frame: During the surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	74
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B: Experimental This group will be the experimental group which will receive tranexamic acid in oral form three days before and six days after surgery.	Drug: Tranexamic acid Oral form, 100mg, tid (three times per day), 3 days before/the day of/6 days after the surgery
A: Placebo Comparator 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).	Drug: Placebo Placebo, Oral form, three times a day, 3 days before/day of/6 days after surgery

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671281

Contacts


Contact: Brad D Mechor, MD	(403)944-3628	bmechor@mac.com

Contact: Scott G Walen, MD	(403)870-8642	swalen@shaw.ca

Locations


Canada, Alberta
	Rockyview General Hospital	Not yet recruiting
	Calgary, Alberta, Canada, T2V 1P9
	Contact: Brad D Mechor, MD (403)944-3628 bmechor@mac.com
	Contact: Scott G Walen, MD (403)870-8642 swalen@shaw.ca
	Sub-Investigator: Warren K Yunker, MD, PhD

Sponsors and Collaborators

University of Calgary

Investigators


Principal Investigator:	Brad D Mechor, MD	Division of Otolaryngology, University of Calgary

More Information

Publications:

Osguthorpe JD. Surgical outcomes in rhinosinusitis: what we know. Otolaryngol Head Neck Surg. 1999 Apr;120(4):451-3. No abstract available.

Blumenfeld RJ, Skolnik EM. Intracranial complications of sinus disease. Trans Am Acad Ophthalmol Otolaryngol. 1966 Nov-Dec;70(6):899-908. No abstract available.

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.

Morgan PR, Morrison WV. Complications of frontal and ethmoid sinusitis. Laryngoscope. 1980 Apr;90(4):661-6.

Cumberworth VL, Sudderick RM, Mackay IS. Major complications of functional endoscopic sinus surgery. Clin Otolaryngol Allied Sci. 1994 Jun;19(3):248-53.

Goldwyn RM. Unexpected bleeding after elective nasal surgery. Ann Plast Surg. 1979 Mar;2(3):201-4.

Dunn CJ, Goa KL. Tranexamic acid: a review of its use in surgery and other indications. Drugs. 1999 Jun;57(6):1005-32. Review.

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.

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.

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.

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.

Responsible Party:	Division of Otolaryngology, University of Calgary ( Dr. Brad Mechor )
Study ID Numbers:	Tranexamic Acid in FESS
First Received:	April 30, 2008
Last Updated:	May 4, 2008
ClinicalTrials.gov Identifier:	NCT00671281
Health Authority:	Canada: Health Canada

Keywords provided by University of Calgary:

FESS

Tranexamic acid

Hemostasis

Visualization

Study placed in the following topic categories:

Antiplasmin

Otorhinolaryngologic Diseases

Respiratory Tract Infections

Respiratory Tract Diseases

Postoperative Complications

Postoperative Hemorrhage

Tranexamic Acid

Sinusitis

Hemorrhage

Additional relevant MeSH terms:

Fibrin Modulating Agents

Antifibrinolytic Agents

Pathologic Processes

Coagulants

Molecular Mechanisms of Pharmacological Action

Paranasal Sinus Diseases

Therapeutic Uses

Hematologic Agents

Hemostatics

Pharmacologic Actions

Nose Diseases

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	University of Calgary
Information provided by:	University of Calgary
ClinicalTrials.gov Identifier:	NCT00671281