Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001512112
Ethics application status
Approved
Date submitted
14/10/2019
Date registered
1/11/2019
Date last updated
15/09/2021
Date data sharing statement initially provided
1/11/2019
Date results information initially provided
15/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of direct application of tranexamic acid at the end of sinus surgery on patient recovery
Scientific title
A pilot study of the impact of topical tranexamic acid at the conclusion of endoscopic sinus surgery for chronic rhinosinusitis on patient recovery
Secondary ID [1] 299541 0
None
Universal Trial Number (UTN)
U1111-1242-0177
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic rhinosinusitis 314798 0
Condition category
Condition code
Surgery 313137 313137 0 0
Other surgery
Respiratory 313138 313138 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: application of 5ml of tranexamic acid (500mg / 5ml) topically to the sinus and nasal mucosa for 60 minutes after endoscopic sinus surgery via cotton pledgets
No issue with adherence as patients anaesthetised / emerging from anaesthesia.
Intervention code [1] 315794 0
Treatment: Drugs
Comparator / control treatment
Control: application of 5ml of normal saline (0.9% sodium chloride) topically to the sinus and nasal mucosa for 60 minutes after endoscopic sinus surgery via cotton pledgets
Control group
Placebo

Outcomes
Primary outcome [1] 321666 0
% reduction in patient reported 22-item sino-nasal outcome tool (SNOT-22)
Timepoint [1] 321666 0
3 months post-operative
Secondary outcome [1] 375812 0
Modified Lund-McKay Postoperative Endoscopic Score (MLMES)
Timepoint [1] 375812 0
3 months post-operative
Secondary outcome [2] 375813 0
Number of days after surgery when patient returns to full work or normal duties as reported by patient
Timepoint [2] 375813 0
Post-operative
Secondary outcome [3] 375814 0
Patient reported severity of bleeding using Likert scale
Timepoint [3] 375814 0
24 hours after surgery
Secondary outcome [4] 375815 0
Complications as reported by the patient, specifically any thromboembolic events
Timepoint [4] 375815 0
28 days post-operative
Secondary outcome [5] 375816 0
% reduction in patient reported 22-item sino-nasal outcome tool (SNOT-22)
Timepoint [5] 375816 0
2 weeks after surgery
Secondary outcome [6] 375817 0
Modified Lund-McKay Postoperative Endoscopic Score (MLMES)
Timepoint [6] 375817 0
2 weeks after surgery

Eligibility
Key inclusion criteria
Adult patient undergoing comprehensive bilateral endoscopic sinus surgery for the treatment of idiopathic chronic rhinosinusitis as defined by the EPOS 2012 guidelines
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Use of tranexamic acid contraindicated owing to history of clotting disorder or thromboembolic disease.
Condition which is know to predispose to chronic rhinosinusitis (e.g. cystic fibrosis, vasculitis, primary ciliary dyskinesia)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
One member of the study team will be unblinded and will randomise the patients and then draw up either tranexamic acid or saline out of sight from other investigators.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2020
Actual
25/02/2020
Date of last participant enrolment
Anticipated
30/09/2020
Actual
28/01/2021
Date of last data collection
Anticipated
31/12/2020
Actual
28/04/2021
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 21920 0
New Zealand
State/province [1] 21920 0
Waikato

Funding & Sponsors
Funding source category [1] 304031 0
University
Name [1] 304031 0
The University of Auckland
Country [1] 304031 0
New Zealand
Funding source category [2] 305236 0
Charities/Societies/Foundations
Name [2] 305236 0
Waikato Medical Research Foundation
Country [2] 305236 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
The University of Auckland
Waikato Clinical Campus
Waikato Hospital
Pembroke Street
Hamilton 3204
Country
New Zealand
Secondary sponsor category [1] 304211 0
None
Name [1] 304211 0
Address [1] 304211 0
Country [1] 304211 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304522 0
Health and Disability Ethics Committee
Ethics committee address [1] 304522 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 304522 0
New Zealand
Date submitted for ethics approval [1] 304522 0
31/10/2019
Approval date [1] 304522 0
07/02/2020
Ethics approval number [1] 304522 0

Summary
Brief summary
Endoscopic sinus surgery (ESS) is recognised to be an effective treatment for chronic rhinosinusitis but the ideal post-operative care after ESS is not defined.
Tranexamic acid (TXA) is a cheap, readily available medication that stabilises blood clot formation. There are limited data regarding the use of intraoperative topical TXA in ESS with promising results but no studies in the published literature regarding post-operative outcomes.
The study hypothesis is that direct application of TXA after ESS improves outcomes and patient recovery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97250 0
Dr Andrew Wood
Address 97250 0
The University of Auckland
Waikato Clinical Campus
Waikato Hospital
Pembroke Street
Hamilton 3204
Country 97250 0
New Zealand
Phone 97250 0
+64 9 373 7599
Fax 97250 0
Email 97250 0
[email protected]
Contact person for public queries
Name 97251 0
Dr Andrew Wood
Address 97251 0
The University of Auckland
Waikato Clinical Campus
Waikato Hospital
Pembroke Street
Hamilton 3204
Country 97251 0
New Zealand
Phone 97251 0
+64 9 373 7599
Fax 97251 0
Email 97251 0
[email protected]
Contact person for scientific queries
Name 97252 0
Dr Andrew Wood
Address 97252 0
The University of Auckland
Waikato Clinical Campus
Waikato Hospital
Pembroke Street
Hamilton 3204
Country 97252 0
New Zealand
Phone 97252 0
+64 9 373 7599
Fax 97252 0
Email 97252 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.