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

NCT00671281 | Withdrawn

• 1 other identifier: Tranexamic Acid in FESS
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Sinusitis

Keywords

FESS; Tranexamic acid; Hemostasis; Visualization

Outcome Measures

Primary Outcomes (1)

• Intraoperative bleeding amount

  During the surgery

Secondary Outcomes (2)

• Surgical visualization scoring

  During the surgery

• Postoperative bleeding events

  Six days after the surgery

Study Arms (2)

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

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

Interventions

Tranexamic acid DRUG

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

Also known as: Cyclokapron

B

Placebo DRUG

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

A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic sinusitis requiring bilateral functional endoscopic sinus surgery
• Between the ages of 18-65
• Willing to comply with standard followup
• No coagulopathy
• Not pregnant

You may not qualify if:

• Pregnant
• On anticoagulants within 3 months of the surgery
• Coagulopathy
• \<18 or \>65 years of age

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Rockyview General Hospital

Calgary, Alberta, T2V 1P9, Canada

Location

Related Publications (11)

• Osguthorpe JD. Surgical outcomes in rhinosinusitis: what we know. Otolaryngol Head Neck Surg. 1999 Apr;120(4):451-3. doi: 10.1053/hn.1999.v120.a95228. No abstract available.

  PMID: 10187931 BACKGROUND

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

  PMID: 5971474 BACKGROUND

• 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. doi: 10.1288/00005537-199103000-00003.

  PMID: 2000009 BACKGROUND

• Morgan PR, Morrison WV. Complications of frontal and ethmoid sinusitis. Laryngoscope. 1980 Apr;90(4):661-6. doi: 10.1288/00005537-198004000-00013.

  PMID: 7359985 BACKGROUND

• Cumberworth VL, Sudderick RM, Mackay IS. Major complications of functional endoscopic sinus surgery. Clin Otolaryngol Allied Sci. 1994 Jun;19(3):248-53. doi: 10.1111/j.1365-2273.1994.tb01225.x.

  PMID: 7923850 BACKGROUND

• Goldwyn RM. Unexpected bleeding after elective nasal surgery. Ann Plast Surg. 1979 Mar;2(3):201-4. doi: 10.1097/00000637-197903000-00004.

  PMID: 539747 BACKGROUND

• Dunn CJ, Goa KL. Tranexamic acid: a review of its use in surgery and other indications. Drugs. 1999 Jun;57(6):1005-32. doi: 10.2165/00003495-199957060-00017.

  PMID: 10400410 BACKGROUND

• 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.

  PMID: 16686395 BACKGROUND

• 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. doi: 10.1016/0003-4975(94)91636-5.

  PMID: 7526811 BACKGROUND

• 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. doi: 10.1067/mtc.2002.120717.

  PMID: 12063454 BACKGROUND

• 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.

  PMID: 16270608 BACKGROUND

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Brad D Mechor, MD

  Division of Otolaryngology, University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 30, 2008
• First Posted: May 5, 2008
• Study Start: October 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 3, 2010

Record last verified: 2010-09

Locations

CA (1)