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Trial registered on ANZCTR


Registration number
ACTRN12619000837123
Ethics application status
Approved
Date submitted
1/04/2019
Date registered
11/06/2019
Date last updated
11/06/2019
Date data sharing statement initially provided
11/06/2019
Date results information initially provided
11/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Transexemic acid use in total knee replacements
Scientific title
The use of transexemic acid in total knee arthroplasty and incidence of venous thromboemboli
Secondary ID [1] 297859 0
NIL KNOWN
Universal Trial Number (UTN)
U1111-1230-9883
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee osteoarthritis 312230 0
venous thromboembolism 312231 0
Condition category
Condition code
Blood 310778 310778 0 0
Clotting disorders
Musculoskeletal 310796 310796 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A retrospective audit of consecutive patients undergoing a TJR between July 2016 and
June 2018 was performed at TQEH. Patient demographics, history of thromboembolic
events and American Society of Anaesthesiologists (ASA) scores were identified. This was
then analysed against the incidence of a post-operative thromboembolic event. Patients
who did not receive TXA were further investigated as to the reason for withholding.
Intervention code [1] 314094 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319626 0
incidence of primary VTE determined by data-linkage to medical records
Timepoint [1] 319626 0
3 months post operative
Secondary outcome [1] 368920 0
blood loss assess by data-linkage to medical records
Timepoint [1] 368920 0
one week post operative
Secondary outcome [2] 368921 0
post operative complications following knee replacement determined from data-linkage to medical records. Routine post op complications include medical and surgical complications especially DVT, PE, transfusion, infection, death
Timepoint [2] 368921 0
3 months post surgery
Secondary outcome [3] 368988 0
frequency of transfusion assessed by data-linkage to medical records
Timepoint [3] 368988 0
one week post surgery

Eligibility
Key inclusion criteria
consecutive patients undergoing a TJR between July 2016 and
June 2018 was performed at TQEH.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
nil

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
comparison of means and A multiple logistic regression model

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)
SA
Recruitment hospital [1] 13532 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 26154 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 302384 0
Self funded/Unfunded
Name [1] 302384 0
Address [1] 302384 0
Country [1] 302384 0
Primary sponsor type
Individual
Name
David Campbell
Address
Department of Orthopaedics
The Queen Elizabeth Hospital
Woodvillle South Australia 5011
Country
Australia
Secondary sponsor category [1] 302275 0
None
Name [1] 302275 0
Address [1] 302275 0
Country [1] 302275 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303057 0
Central Adelaide Local Health Network Human Research Ethics Committee (CALHN HREC)
Ethics committee address [1] 303057 0
Central Adelaide Local Health Network Human Research Ethics Committee (CALHN HREC)
CALHN Research Office
L3 Roma Mitchell House, North Terrace, Adelaide
South Australia 5000
Ethics committee country [1] 303057 0
Australia
Date submitted for ethics approval [1] 303057 0
Approval date [1] 303057 0
03/02/2019
Ethics approval number [1] 303057 0
HREC/18/CALHN/704

Summary
Brief summary
Introduction & aims
Tranexamic acid (TXA) is an anti-fibrinolytic historically been used to reduce haemorrhage
during trauma. Its benefits in reducing the blood loss and subsequent blood transfusions
after elective total joint replacements (TJR) have been widely accepted. Despite this,
tranexamic acid has yet to be routinely used in all patients – mostly due to the theoretical
concern of an increased incidence of venous thromboembolism.
This study aims to determine whether the use of TXA in TJR increases the risk of venous
thromboembolism.
Method
A retrospective audit of consecutive patients undergoing a TJR between July 2016 and
June 2018 was performed at TQEH. Patient demographics, history of thromboembolic
events and American Society of Anaesthesiologists (ASA) scores were identified. This was
then analysed against the incidence of a post-operative thromboembolic event. Patients
who did not receive TXA were further investigated as to the reason for withholding
Trial website
Trial related presentations / publications
Public notes
study commenced as departmental audit and proceeded ethics approval. Data remained confidential until ethics approval obtained.

Contacts
Principal investigator
Name 92310 0
A/Prof David Campbell
Address 92310 0
Wakefield Orthopaedic Clinic
270 Wakefield Street
Adelaide 5000
South Australia
Country 92310 0
Australia
Phone 92310 0
+61 8 82364196
Fax 92310 0
Email 92310 0
hipknee@tpg.com.au
Contact person for public queries
Name 92311 0
A/Prof David Campbell
Address 92311 0
Wakefield Orthopaedic Clinic
270 Wakefield Street
Adelaide 5000
South Australia
Country 92311 0
Australia
Phone 92311 0
+61 8 82364196
Fax 92311 0
Email 92311 0
hipknee@tpg.com.au
Contact person for scientific queries
Name 92312 0
A/Prof David Campbell
Address 92312 0
Wakefield Orthopaedic Clinic
270 Wakefield Street
Adelaide 5000
South Australia
Country 92312 0
Australia
Phone 92312 0
+61 8 82364196
Fax 92312 0
Email 92312 0
hipknee@tpg.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
confidential
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?
No
Results – basic reporting
Results – plain English summary
466 cases were identified. 85% of patients with a history of VTE and 87% of patients
without a history of VTE received TXA intraoperatively. There was no significance in rate of
post-operative VTE between patients given TXA vs those not given. Of the
patients who received TXA, no patients with a history of VTE had a post-operative VTE
(n=33) whilst ten patients without a history of VTE had a post-operative VTE (n=373). A multiple logistic regression model was used which did not demonstrate any
significant difference between TXA use and VTE rate controlling for other independent
variables. Our analysis found that there was a trend (p=0.06) towards males have a
greater rate of VTE complications (4.6%) compared with females (1.7%).
Independently there was a significant reduction in blood loss and
transfusions. Iin patients who received routine TXA. Controlling for independent
variables (age, sex, joint, BMI, ASA, Tourniquet use, IDC use), the subsequent reduction in
blood loss and transfusion rate was still significant. ASA score was
found to significantly increase the chance of transfusions but not blood loss.