Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000926437
Ethics application status
Approved
Date submitted
23/07/2025
Date registered
26/08/2025
Date last updated
26/08/2025
Date data sharing statement initially provided
26/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Extended Postoperative Oral Tranexamic Acid In Total Hip and Knee Arthroplasty: A Randomised Controlled Study
Scientific title
Extended Postoperative Oral Tranexamic Acid on Patient-Reported and Functional Outcomes In Total Hip and Knee Arthroplasty: A Randomised Controlled Study
Secondary ID [1] 314981 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Hip Arthroplasty 338297 0
Total Knee Arthroplasty 338298 0
Osteoarthritis 338299 0
Condition category
Condition code
Musculoskeletal 334595 334595 0 0
Osteoarthritis
Surgery 334596 334596 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ‘treatment group’ will receive the TXA dose intravenously, 1 gram at the start of procedure and 1 gram before the wound closure PLUS additional once daily oral tablets of TXA 2 grams (4 x 500 mgs capsules) on the day of surgery (at least 8 hours after the last IV dose), and for 3 subsequent days. The TXA intravenous dose in operating room will be administered by the anesthetist. The oral TXA dose in acute stay will be administered by the nursing staff.
Intervention code [1] 331571 0
Treatment: Drugs
Comparator / control treatment
The control group will receive the TXA dose intravenously ONLY, without the extended oral TXA dose, 1 gram at the start of procedure and 1 gram before the wound closure. The TXA intravenous dose in operating room will be administered by the anesthetist.
Control group
Dose comparison

Outcomes
Primary outcome [1] 342270 0
Patient-Reported Outcomes Measures specific to total hip arthroplasty (THA)
Timepoint [1] 342270 0
2 weeks, 6 weeks and 6 months following the surgery.
Primary outcome [2] 342393 0
Patient-Reported Outcomes Measures specific to total knee arthroplasty (TKA)
Timepoint [2] 342393 0
2 weeks, 6 weeks and 6 months following the surgery
Secondary outcome [1] 450206 0
Joint Pain Score
Timepoint [1] 450206 0
average score during acute stay; and week 2 and 6, and 6 months following the surgery
Secondary outcome [2] 450207 0
Knee Range of Motion (ROM) - Flexion
Timepoint [2] 450207 0
6 weeks following surgery
Secondary outcome [3] 450667 0
Knee Range of Motion (ROM) -Extension
Timepoint [3] 450667 0
6 weeks following surgery

Eligibility
Key inclusion criteria
• Unilateral primary elective THA or TKA patients under the care of the investigating surgeons, with the underlying diagnosis of osteoarthritis at the Mater Hospital North Sydney
• Age 18-year-old or older
• Ability to give written informed consent and willingness to comply with the requirement of the study, including but not limited to the randomisation process.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Participants with the history of venous thromboembolism (VTE), such as deep vein thrombosis (DVT), pulmonary embolism (PE) and cerebral thrombosis in the last 6 months
• Participants who are allergic to TXA or Aspirin
• Participants who are hypersensitive to TXA or any of its non-active ingredients.
• Participants who are already on antiplatelets medication preoperatively other than Aspirin
• Participants with subarachnoid haemorrhage
• Significant medical history for liver and renal insufficiency (such as chronic kidney disease, renal failure, kidney transplant, haematuria, dialysis)
• Participants with a blood clotting disorders or thrombophilias
• Participants with anaemia with Hb <90 g/L preoperatively,
• Participants with intraoperative complications requiring immediate intervention/s, which will intervene the standard routine post-operative care following THA or TKA (i.e perioperative fractures, vascular injuries, unplanned ICU admission)
• Participants who are pregnant or breastfeeding
• Participants with acquired disturbances of colour vision
• Participants with a history of a psychological illness or condition such as to interfere with the ability to understand the requirements of the study, or complete the survey

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A statistical software, STATA 18 (StataCorp LLC) will be utilised to create a randomised sequence allocation for the participants to either the ‘standard’ or ‘extended’ group, on a ratio of 1:1. The sequence allocation will be performed separately for THA and TKA patients. The simple randomisation is chosen for the purpose of his study. The total participants proposed for this study is 100 THA and TKA patients respectively. Fifty patients will be allocated to either standard and treatment arm, in TKA and THA cohort respectively. To ensure equal allocation of participants (n=100) in the knee and hip procedures, 2 subgroups (strata) will be created, one for hip and one for knee procedures. Within each strata simple randomisation will be performed.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
5/04/2027
Actual
Date of last data collection
Anticipated
4/10/2027
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 28236 0
Mater Sydney - North Sydney
Recruitment postcode(s) [1] 44447 0
2060 - North Sydney

Funding & Sponsors
Funding source category [1] 319533 0
Other Collaborative groups
Name [1] 319533 0
North Sydney Orthopaedic Research Group
Country [1] 319533 0
Australia
Primary sponsor type
Other Collaborative groups
Name
North Sydney Orthopaedic Research Group
Address
Country
Australia
Secondary sponsor category [1] 322033 0
None
Name [1] 322033 0
Address [1] 322033 0
Country [1] 322033 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318108 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 318108 0
Ethics committee country [1] 318108 0
Australia
Date submitted for ethics approval [1] 318108 0
04/06/2025
Approval date [1] 318108 0
02/07/2025
Ethics approval number [1] 318108 0
2025/ETH00869

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 143142 0
Prof William L Walter
Address 143142 0
Mater Clinic, Suite 1.18, 3-9 Gillies Street, Wollstonecraft, NSW 2065
Country 143142 0
Australia
Phone 143142 0
+61 2 9409 0530
Fax 143142 0
Email 143142 0
[email protected]
Contact person for public queries
Name 143143 0
Kaka Martina and Lucy Salmon
Address 143143 0
Mater Clinic, Suite 1.18, 3-9 Gillies Street, Wollstonecraft, NSW 2065
Country 143143 0
Australia
Phone 143143 0
+61 2 9409 0530
Fax 143143 0
Email 143143 0
[email protected]
Contact person for scientific queries
Name 143144 0
Kaka Martina and Lucy Salmon
Address 143144 0
Mater Clinic, Suite 1.18, 3-9 Gillies Street, Wollstonecraft, NSW 2065
Country 143144 0
Australia
Phone 143144 0
+61 2 9409 0530
Fax 143144 0
Email 143144 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Data collected for this clinical trial will remain confidential. Individual participant data will not be shared.



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.