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Trial registered on ANZCTR


Registration number
ACTRN12617001074381
Ethics application status
Approved
Date submitted
20/07/2017
Date registered
25/07/2017
Date last updated
29/11/2021
Date data sharing statement initially provided
27/11/2018
Date results information initially provided
22/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Intravenous tranexamic acid ("TXA") and its effect on post-operative pain and stiffness in patients undergoing total shoulder arthroscopy and rotator cuff repair.
Scientific title
Effect of systemic tranexamic acid use on post-operative pain and stiffness in patients undergoing shoulder arthroscopy and rotator cuff repair.
Secondary ID [1] 292473 0
None
Universal Trial Number (UTN)
U1111-1198-4568
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain and stiffness after shoulder arthroscopy and rotator cuff repair 304094 0
Condition category
Condition code
Musculoskeletal 303430 303430 0 0
Other muscular and skeletal disorders
Surgery 303431 303431 0 0
Other surgery
Anaesthesiology 303456 303456 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1 (TXA group) will receive 2000mg (20ml) of Tranexamic Acid (TXA) intravenously 5 minutes before incision.
Intervention code [1] 298656 0
Treatment: Drugs
Comparator / control treatment
Group 2 (Control group) will receive 2000mg (20ml) of Saline intravenously 5 minutes before incision.
Control group
Placebo

Outcomes
Primary outcome [1] 302812 0
Range of Motion in the operated shoulder will be assessed using a goniometer and the ASES (American Shoulder and Elbow Society Score). Treatment group will be compared with control group.
Timepoint [1] 302812 0
8 weeks and 24 weeks post-surgery, with 24 weeks being the primary endpoint.
Primary outcome [2] 302813 0
Pain in treatment group versus control group will be assessed using the 100mm visual analogue scale as well as a pain questionnaire which asks the patient to rate (from 1 to 10) their pain at its worst and at its best during the last 24 hours.
Timepoint [2] 302813 0
72 hours (3 days), 8 weeks and 24 weeks post-surgery, with 24 weeks being the primary endpoint.
Secondary outcome [1] 337132 0
Occurrence of postoperative haematoma as measured by data linkage to patient medical records.
Timepoint [1] 337132 0
Within 6 weeks after intervention commencement.

Eligibility
Key inclusion criteria
1. Patients who have consented for shoulder arthroscopy and rotator cuff repair under one of the investigators.
2. Patients who are capable of and have given informed consent for their participation in this study.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients allergic to tranexamic acid
2. Patients with a failed rotator cuff repair requiring revision
3. Patients with history of deep venous thrombosis or pulmonary embolism
4. Patients with cardiovascular disease, including coronary disease or peripheral arteriopathy
5. Patients with renal or liver failure
6. Patients with a known coagulopathy
7. Patients that refuse a potential transfusion

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)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
None
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Correlation analysis, including univariate and multivariate analyses will be used to determine the correlation between systemic administration of TXA and the selected outcome criteria. P value <0.5 will be considered as statistically significant. All data will be entered into Socrates Orthopaedic Outcomes Software (Ortholink Pty Ltd, Sydney, Australia).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8567 0
North Shore Private Hospital - St Leonards
Recruitment hospital [2] 8568 0
Mater Sydney - North Sydney
Recruitment postcode(s) [1] 16672 0
2065 - St Leonards
Recruitment postcode(s) [2] 16673 0
2060 - North Sydney

Funding & Sponsors
Funding source category [1] 297040 0
Other Collaborative groups
Name [1] 297040 0
Sydney Shoulder Research Institute
Address [1] 297040 0
Suite 201 Level 2 156 Pacific Highway St Leonards NSW 2065
Country [1] 297040 0
Australia
Primary sponsor type
Individual
Name
Dr Benjamin Cass
Address
Sydney Shoulder Research Institute
Suite 201
Level 2
156 Pacific Highway
St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 296048 0
None
Name [1] 296048 0
Address [1] 296048 0
Country [1] 296048 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298224 0
North Shore Private Hospital Ethics Committee
Ethics committee address [1] 298224 0
North Shore Private Hospital
3 Westbourne Street
St Leonards NSW 2065
Ethics committee country [1] 298224 0
Australia
Date submitted for ethics approval [1] 298224 0
26/07/2017
Approval date [1] 298224 0
21/08/2017
Ethics approval number [1] 298224 0
NSPHEC 2017-008
Ethics committee name [2] 298226 0
St Vincent's Hospital Sydney Human Research Ethics Committee
Ethics committee address [2] 298226 0
Research Office
Level 6
de Lacy Building
St Vincent's Hospital
390 Victoria Street
Darlinghurst NSW 2010
Ethics committee country [2] 298226 0
Australia
Date submitted for ethics approval [2] 298226 0
31/07/2017
Approval date [2] 298226 0
12/09/2017
Ethics approval number [2] 298226 0
HREC/17/SVH/174

Summary
Brief summary
This will be a multicentre multisurgeon prospective doubleblinded randomized and controlled trial looking at the effectiveness of single dose intravenous administration of Tranexamic Acid (TXA) in patients undergoing shoulder arthroscopy and rotator cuff repair.

The aim of this study is to extend Level I category evidence of the known benefits of TXA to shoulder arthroscopy and rotator cuff repair. The primary objective of this study is to test the hypothesis that systemic use of tranexamic acid decreases postoperative pain and stiffness.

All consecutive patients presenting to an elective orthopaedic consultation indicated for shoulder arthroscopy and rotator cuff repair will be considered eligible for this study. After having been screened for inclusion and exclusion criteria, read the information sheet and signed the consent form, patients will be blindly randomized to one of 2 groups: Systemic TXA or Control.

Patients’ general demographic characteristics such as age, sex, dominance, diagnosis and other relevant comorbidities will be collected in a deidentified database locked on a password-protected computer.

During the surgery, patients will be administered either 2000mg of intravenous TXA or a placebo equivalent (saline solution). Analysed outcome variables will include: occurrence of postoperative haematoma, postoperative pain Visual Analog Scale (pVAS), range of motion at 8 weeks and 24 weeks.
Trial website
None. But will be listed on www.ssri.net.au (the Sponsor's website) under "Current Research Projects" once ethics approval has been granted.
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76398 0
Dr Benjamin Cass
Address 76398 0
Sydney Shoulder Research Institute
Suite 201
Level 2
156 Pacific Highway
St Leonards NSW 2065
Country 76398 0
Australia
Phone 76398 0
+61 2 9460 8888
Fax 76398 0
+61 2 9460 6064
Email 76398 0
cassadmin@sydneyshoulder.com.au
Contact person for public queries
Name 76399 0
Miss Jasmin Gwynne
Address 76399 0
Sydney Shoulder Research Institute
Suite 201
Level 2
156 Pacific Highway
St Leonards NSW 2065
Country 76399 0
Australia
Phone 76399 0
+61 2 9460 8813
Fax 76399 0
+61 2 9460 6064
Email 76399 0
jasmin@sydneyshoulder.com.au
Contact person for scientific queries
Name 76400 0
Dr Benjamin Cass
Address 76400 0
Sydney Shoulder Research Institute
Suite 201
Level 2
156 Pacific Highway
St Leonards NSW 2065
Country 76400 0
Australia
Phone 76400 0
+61 2 9460 8888
Fax 76400 0
+61 2 9460 6064
Email 76400 0
cassadmin@sydneyshoulder.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
After analysis is completed, all study data will be deidentified, stored confidentially and not be used for any further research unless further ethics approval is granted.

What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary