Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001327875
Ethics application status
Approved
Date submitted
9/08/2021
Date registered
29/09/2021
Date last updated
29/09/2021
Date data sharing statement initially provided
29/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of tranexamic acid on recovery time in patients undergoing total knee replacements
Scientific title
A prospective, randomised non-blinded pilot study to investigate the effect of oral tranexamic acid on the recovery time in patients undergoing primary total knee arthroplasty.
Secondary ID [1] 304971 0
TXA002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Knee Arthroplasty 323116 0
Peri-operative bleeding with Total Knee Arthroplasty 323117 0
Condition category
Condition code
Surgery 320699 320699 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised non-blinded pilot study for the use of Tranexamic Acid in patients that are undergoing Total Knee Arthroscopy, performed as per hospital policy. A total of 40 participants per treatment arm will be examined, 80 in total. This allows for an estimated drop-out rate of 15%.
Participants will be screened and eligibility assessed from surgeons preoperative list. Once consent is completed a baseline visit will be completed including blood tests (including baseline Heamoglobin -Hb) as standard of care. Day 0- Preoperatively the following assessments will be completed: Oxford Knee Score, knee girth, range of motion, pain assessment by the anesthetist. These assessments will be repeated throughout the post operative phase whist the participant is in hospital on Day 1,2,3,4 by the physiotherapist and ward Registered nurse.

All participants will receive intravenous Tranexamic acid which is standard practice Day 0- pre operatively before undergoing TKA. The alternative treatments will be randomly allocated with a 1:1 allocation to groups. Participants will be randomised at study entry. An independent statistician will conduct randomisation.
Arm 1: Tranexamic Acid 1.0 gram Intravenously, on induction of anaesthesia by the anesthetist.
Arm 2: Tranexamic Acid 1.0 gram Intravenously, on induction of anaesthesia by the anaesthetist. A further 6 doses of oral Tranexamic Acid 2.0 grams every 8 hours post-operatively will be administered by registered nurses on the ward.

Preoperative, intraoperative and post operative procedural information, will be reviewed and the dosage of TXA and will be recorded by study staff in the source documentation. This is to verify the pre operative dosing of Intravenous TXA has been administered. This will be done on day 1,2,3,4 or day of discharge.
During the post operative phase on Day 1,2,3 and 4 the inpatient medication chart will be reviewed by the anesthetist or study staff to verify that the oral doses of TXA have been administered, this will be documented in the source data.

Blood Draw on day 4 or on discharge if< day 4, to assess blood loss by calculating the difference between baseline (heamoglobin (Hb) and the lowest post-operative Hb during hospital stay.

As per standard of care participants will be discharged on day 4 post operatively with follow up at 6 weeks during the standard follow up surgical appointment, the Oxford Knee Score will be recorded and range of motion will be completed by the Surgeon. Final follow up at 6 months with the final Oxford Knee Score assessment by the Study Co-Ordinator.
A total duration of participation in the study is 6 months.


Intervention code [1] 321370 0
Treatment: Drugs
Comparator / control treatment
Arm 1: Tranexamic Acid 1.0 gram Intravenously, on induction of anaesthesia by the anaesthetist.
Control group
Active

Outcomes
Primary outcome [1] 328526 0
Blood loss, calculated as difference between admission haemoglobin and the lowest post-operative haemoglobin during hospital stay or prior to blood transfusion will be collected by reviewing medical records to document haemoglobin level.
Timepoint [1] 328526 0
Baseline, day one post-operatively and day 4 post-operatively
Secondary outcome [1] 399332 0
Time taken to achieve 90% knee flexion, using a double armed goniometer by the number of degrees from the starting position of the knee joint to its position at the end of its full range of the movement. Recorded as a % in change.
Timepoint [1] 399332 0
Day 0 pre-operatively, post operatively. day 1,2,3,4 and 6 weeks.
% change recorded from days 2,3,4.
Secondary outcome [2] 399333 0
Pain measurement each day whilst in hospital prior to discharge using verbal pain score of 0-10 to be recorded in source documents.
Timepoint [2] 399333 0
Day 0 pre operatively, post operatively day 1,2,3,4
Secondary outcome [3] 400618 0
Change in mid patella knee girth in centimeters as a percentage increase, using a paper tape measure
Timepoint [3] 400618 0
Day 0 pre-operatively.
Post operatively day 2,3,4
Secondary outcome [4] 400619 0
Functional outcome (Oxford Knee score)
The participant's perspective of outcome following their TKA will be assessed using the Oxford Knee Score, Participants will be complete the assessment in writing.
Timepoint [4] 400619 0
Pre-operatively, 6 weeks and 6 months post-operatively.

Eligibility
Key inclusion criteria
1. Participants of either sex scheduled to undergo a primary, unilateral Total Knee Arthroplasty.
2. Available for follow up at 6 months post-surgery.
3. Willingness to provide written, informed consent.
4. Willingness to comply with the study.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known allergy to TXA
2, Acquired disturbances to colour vision
3, Preoperative use of anticoagulants (within 5 days of surgery)
4. Fibrinolytic disorders requiring intraoperative fibrinolytics
5. Coagulopathy, history of arteriolar or venous thromboembolic disease
6. Pregnancy or breastfeeding
7. Haemoglobin <10g/dL

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)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerized sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
80 participants in total 40 per arm, allowing for a 15 percent drop out rate.
The primary outcome, between-group difference in time to achieve >90 degrees flexion, will be assessed using the logrank test. Secondary outcomes measured on the interval scale will be compared between groups using linear regression, and binary outcomes will be compared using logistic regression. If statistical assumptions are not met, non-parametric tests will be used. Analyses will be conducted on an 'intention-to-treat' basis and a p-value <0.05 will be considered significant. An interim analysis will not be performed as part of the study

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2021
Actual
Date of last participant enrolment
Anticipated
30/06/2022
Actual
Date of last data collection
Anticipated
19/06/2023
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 20145 0
Brisbane Private Hospital - Brisbane
Recruitment hospital [2] 20146 0
The Wesley Hospital - Auchenflower
Recruitment postcode(s) [1] 34872 0
4000 - Brisbane
Recruitment postcode(s) [2] 34873 0
4066 - Auchenflower

Funding & Sponsors
Funding source category [1] 309357 0
Charities/Societies/Foundations
Name [1] 309357 0
Wesley Medical Research
Country [1] 309357 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Wesley Medical Research
Address
Level 8, East Wing, The Wesley Hospital
451 Coronation Drive
Auchenflower, Qld 4066
Country
Australia
Secondary sponsor category [1] 310325 0
None
Name [1] 310325 0
Address [1] 310325 0
Country [1] 310325 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309173 0
UnitingCare Health Human Research Ethics Committee
Ethics committee address [1] 309173 0
Moorlands House, The Wesley Hospital, 451 Coronation Drive, Auchenflower, Qld 4066
Ethics committee country [1] 309173 0
Australia
Date submitted for ethics approval [1] 309173 0
04/11/2020
Approval date [1] 309173 0
24/11/2020
Ethics approval number [1] 309173 0
2015

Summary
Brief summary
The purpose of the study is to evaluate a product called Tranexamic Acid (TXA) and its best use in patients who are undergoing total knee replacement.
The product is currently used to reduce bleeding during and after surgical procedures. This can lessen the chance of a blood transfusion and may decrease pain, swelling and recovery time following the operation.
Tranexamic Acid is already routinely used by surgeons for patients having joint replacements but there is currently no accurate information about how to dose individual patients with this medication to achieve the best results.
This study will assess whether different treatment durations and doses will lead to better patient outcomes.
The form of TXA that we are using in this study is one single dose in the vein-intravenously and/or an oral tablet.
There are 2 treatment groups:
Group 1 –Receives 1 gram of TXA intravenously 1 hour prior to surgery
Group 2 – Receives 1 gram of TXA intravenously TXA 1 hour before surgery and post-operatively oral dose of 2 grams 8th hourly for a total of 6 doses.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113238 0
A/Prof Susan Clark
Address 113238 0
Wesley Anesthesia and Pain Management
Suite 17, Level 2, Wesley Medical Centre
40 Chasley St
Auchenflower, QLD, 4066 Australia
Country 113238 0
Australia
Phone 113238 0
+61 412 578 743
Fax 113238 0
+61 738703139
Email 113238 0
[email protected]
Contact person for public queries
Name 113239 0
Susan Clark
Address 113239 0
Wesley Anesthesia and Pain Management
Suite 17, Level 2, Wesley Medical Centre
40 Chasley St
Auchenflower, QLD, 4066 Australia
Country 113239 0
Australia
Phone 113239 0
+61 733770500
Fax 113239 0
+61 738703139
Email 113239 0
[email protected]
Contact person for scientific queries
Name 113240 0
Susan Clark
Address 113240 0
Wesley Anesthesia and Pain Management
Suite 17, Level 2, Wesley Medical Centre
40 Chasley St
Auchenflower, QLD, 4066 Australia
Country 113240 0
Australia
Phone 113240 0
+61 733770500
Fax 113240 0
+61 738703139
Email 113240 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.