Chronic SinusitisNCT00671281
The Effect of Tranexamic Acid on Intraoperative and Post-Operative Bleeding in Functional Endoscopic Sinus Surgery
A study testing Tranexamic acid in people with Chronic Sinusitis, run by University of Calgary at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Sinusitis
- What is being tested?
- Tranexamic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic sinusitis requiring bilateral functional endoscopic sinus surgery
- Between the ages of 18-65
- Willing to comply with standard followup
- No coagulopathy
- Not pregnant
Who cannot join
- Pregnant
- On anticoagulants within 3 months of the surgery
- Coagulopathy
- <18 or >65 years of age
Trial locations and contacts
1 site in 1 country.
About this 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
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
- Being tested
- Tranexamic acid, Placebo
- Keywords
- FESS, Tranexamic acid, Hemostasis, Visualization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called Cyclokapron
Oral form, 100mg, tid (three times per day), 3 days before/the day of/6 days after the surgery
PlaceboDrug
Placebo, Oral form, three times a day, 3 days before/day of/6 days after surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative bleeding amount
Measured: During the surgery
Secondary outcomes (2)
Surgical visualization scoring
Measured: During the surgery
Postoperative bleeding events
Measured: Six days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2008 (estimated)
- Study startOct 2008
- Primary completionJun 2009 (estimated)
- Study completionDec 2009 (estimated)
Why it stopped: Study was cancelled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Chronic SinusitisStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Investigators
- Brad D Mechor, MD, Principal investigator, Division of Otolaryngology, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671281
- Sponsor's protocol ID
- Tranexamic Acid in FESS
- Status last verified
- Sep 2010
- First submitted
- 30 Apr 2008
- Last updated
- 3 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10187931Blumenfeld RJ, Skolnik EM. Intracranial complications of sinus disease. Trans Am Acad Ophthalmol Otolaryngol. 1966 Nov-Dec;70(6):899-908. No abstract available.
PubMed 5971474Clayman 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.
PubMed 2000009Morgan PR, Morrison WV. Complications of frontal and ethmoid sinusitis. Laryngoscope. 1980 Apr;90(4):661-6. doi: 10.1288/00005537-198004000-00013.
PubMed 7359985Cumberworth 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.
PubMed 7923850Goldwyn RM. Unexpected bleeding after elective nasal surgery. Ann Plast Surg. 1979 Mar;2(3):201-4. doi: 10.1097/00000637-197903000-00004.
PubMed 539747Dunn 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.
PubMed 10400410Yaniv E, Shvero J, Hadar T. Hemostatic effect of tranexamic acid in elective nasal surgery. Am J Rhinol. 2006 Mar-Apr;20(2):227-9.
PubMed 16686395Fremes 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.
PubMed 7526811Casati 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.
PubMed 12063454Wormald 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.
PubMed 16270608
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tranexamic Acid on Intraoperative and Post-Operative Bleeding in Functional Endoscopic Sinus Surgery: A Randomized, Prospective, Double-Blinded Study
- ClinicalTrials.gov ID
- NCT00671281
- Acronym / sponsor ID
- Tranexamic Acid in FESS
- Conditions
- Chronic Sinusitis
- Keywords
- FESS, Tranexamic acid, Hemostasis, Visualization
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was cancelled
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 5 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Experimental | Drug: Tranexamic acidThis group will be the experimental group which will receive tranexamic acid in oral form three days before and six days after surgery. |
| A | Placebo comparator | Drug: PlaceboThis 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic sinusitis requiring bilateral functional endoscopic sinus surgery
- Between the ages of 18-65
- Willing to comply with standard followup
- No coagulopathy
- Not pregnant
Key exclusion criteria (4 listed)
- Pregnant
- On anticoagulants within 3 months of the surgery
- Coagulopathy
- <18 or >65 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acidAlso: CyclokapronOral form, 100mg, tid (three times per day), 3 days before/the day of/6 days after the surgery | Drug | B |
| PlaceboPlacebo, Oral form, three times a day, 3 days before/day of/6 days after surgery | Drug | A |
Primary outcome
Intraoperative bleeding amount
Time frame: During the surgery
2 secondary outcomes
Surgical visualization scoring
Time frame: During the surgery
Postoperative bleeding events
Time frame: Six days after the surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2010.
- Background: PubMed 10187931Osguthorpe 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.
- Background: PubMed 5971474Blumenfeld RJ, Skolnik EM. Intracranial complications of sinus disease. Trans Am Acad Ophthalmol Otolaryngol. 1966 Nov-Dec;70(6):899-908. No abstract available.
- Background: PubMed 2000009Clayman 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.
- Background: PubMed 7359985Morgan PR, Morrison WV. Complications of frontal and ethmoid sinusitis. Laryngoscope. 1980 Apr;90(4):661-6. doi: 10.1288/00005537-198004000-00013.
- Background: PubMed 7923850Cumberworth 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.
- Background: PubMed 539747Goldwyn RM. Unexpected bleeding after elective nasal surgery. Ann Plast Surg. 1979 Mar;2(3):201-4. doi: 10.1097/00000637-197903000-00004.
- Background: PubMed 10400410Dunn 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.
- Background: PubMed 16686395Yaniv E, Shvero J, Hadar T. Hemostatic effect of tranexamic acid in elective nasal surgery. Am J Rhinol. 2006 Mar-Apr;20(2):227-9.
- Background: PubMed 7526811Fremes 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.
- Background: PubMed 12063454Casati 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.
- Background: PubMed 16270608Wormald 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brad D Mechor, MD principal investigator
Division of Otolaryngology, University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic acid in people with Chronic Sinusitis, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative bleeding amount (time frame: During the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00671281, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2010.