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

Primary Purpose

Chronic Sinusitis

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Tranexamic acid
Placebo
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Sinusitis focused on measuring FESS, Tranexamic acid, Hemostasis, Visualization

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rockyview General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

B

A

Arm Description

This group will be the experimental group which will receive tranexamic acid in oral form three days before and six days after surgery.

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).

Outcomes

Primary Outcome Measures

Intraoperative bleeding amount

Secondary Outcome Measures

Surgical visualization scoring
Postoperative bleeding events

Full Information

First Posted
April 30, 2008
Last Updated
September 2, 2010
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT00671281
Brief Title
The Effect of Tranexamic Acid on Intraoperative and Post-Operative Bleeding in Functional Endoscopic Sinus Surgery
Official Title
The Effect of Tranexamic Acid on Intraoperative and Post-Operative Bleeding in Functional Endoscopic Sinus Surgery: A Randomized, Prospective, Double-Blinded Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Withdrawn
Why Stopped
Study was cancelled
Study Start Date
October 2008 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Calgary

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis
Keywords
FESS, Tranexamic acid, Hemostasis, Visualization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
B
Arm Type
Experimental
Arm Description
This group will be the experimental group which will receive tranexamic acid in oral form three days before and six days after surgery.
Arm Title
A
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Other Intervention Name(s)
Cyclokapron
Intervention Description
Oral form, 100mg, tid (three times per day), 3 days before/the day of/6 days after the surgery
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, Oral form, three times a day, 3 days before/day of/6 days after surgery
Primary Outcome Measure Information:
Title
Intraoperative bleeding amount
Time Frame
During the surgery
Secondary Outcome Measure Information:
Title
Surgical visualization scoring
Time Frame
During the surgery
Title
Postoperative bleeding events
Time Frame
Six days after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brad D Mechor, MD
Organizational Affiliation
Division of Otolaryngology, University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rockyview General Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 1P9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
10187931
Citation
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.
Results Reference
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PubMed Identifier
5971474
Citation
Blumenfeld RJ, Skolnik EM. Intracranial complications of sinus disease. Trans Am Acad Ophthalmol Otolaryngol. 1966 Nov-Dec;70(6):899-908. No abstract available.
Results Reference
background
PubMed Identifier
2000009
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. doi: 10.1288/00005537-199103000-00003.
Results Reference
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PubMed Identifier
7359985
Citation
Morgan PR, Morrison WV. Complications of frontal and ethmoid sinusitis. Laryngoscope. 1980 Apr;90(4):661-6. doi: 10.1288/00005537-198004000-00013.
Results Reference
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PubMed Identifier
7923850
Citation
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.
Results Reference
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PubMed Identifier
539747
Citation
Goldwyn RM. Unexpected bleeding after elective nasal surgery. Ann Plast Surg. 1979 Mar;2(3):201-4. doi: 10.1097/00000637-197903000-00004.
Results Reference
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PubMed Identifier
10400410
Citation
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.
Results Reference
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PubMed Identifier
16686395
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.
Results Reference
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PubMed Identifier
7526811
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. doi: 10.1016/0003-4975(94)91636-5.
Results Reference
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PubMed Identifier
12063454
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. doi: 10.1067/mtc.2002.120717.
Results Reference
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PubMed Identifier
16270608
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.
Results Reference
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The Effect of Tranexamic Acid on Intraoperative and Post-Operative Bleeding in Functional Endoscopic Sinus Surgery

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