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Trial registered on ANZCTR


Registration number
ACTRN12613000323729
Ethics application status
Approved
Date submitted
21/03/2013
Date registered
22/03/2013
Date last updated
24/11/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Tranexamic Acid in Lower Limb Arthroplasty Pilot Trial
Scientific title
The Tranexamic Acid in Lower Limb Arthroplasty Pilot Trial - a pilot trial to examine the feasibility of extension of trial methodology to a large multi-centre randomised controlled trial.
Secondary ID [1] 282156 0
Nil known
Universal Trial Number (UTN)
U1111-1140-8459
Trial acronym
TALLAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip or knee joint replacement 288662 0
Condition category
Condition code
Anaesthesiology 289007 289007 0 0
Anaesthetics
Surgery 289021 289021 0 0
Other surgery
Musculoskeletal 289022 289022 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tranexamic acid - 15mg/kg given intravenously at 50mg/min at skin incision (for total hip replacement) or just prior to tourniquet release (for total knee replacement) and repeated at 8 and 16 hours post-operatively.
Intervention code [1] 286765 0
Treatment: Drugs
Comparator / control treatment
Placebo - normal saline, given in same volume and method as tranexamic acid.
Control group
Placebo

Outcomes
Primary outcome [1] 289123 0
Feasibility of extending our methodology to a large, pragmatic, multicenter trial using the following criteria;
•At least 1 subject per week per centre can be recruited and consented into the trial.
•>90% receive every dose of study drug in a blinded manner
•Full data collection at 6 weeks in >90% participants
•>90% undergo at least 3 out of 4 troponin assays.

Timepoint [1] 289123 0
30 days
Primary outcome [2] 289124 0
Proportion of patients receiving allogeneic blood transfusion
Timepoint [2] 289124 0
30 days
Secondary outcome [1] 301865 0
Incidence of significant clinical events (intended primary endpoints for larger study) at 6 weeks – mortality, myocardial infarction, elevated cardiac markers that do not fulfil criteria for MI, non-fatal cardiac arrest, transient ischemic attack/stroke, deep venous thrombosis, pulmonary embolism, acute kidney injury, atrial fibrillation, infection/sepsis, bleeding, transfusion, congestive heart failure, peripheral arterial thrombosis or coronary intervention
Timepoint [1] 301865 0
6 weeks
Secondary outcome [2] 301866 0
Incidence of surgical complications – need for re-operation (including manipulation under anaesthesia), haemarthrosis, haematoma, infection of wound or joint or wound ooze
Timepoint [2] 301866 0
6 weeks
Secondary outcome [3] 301867 0
Length of ICU and hospital stay
Timepoint [3] 301867 0
6 weeks
Secondary outcome [4] 301868 0
Rate of readmission to hospital
Timepoint [4] 301868 0
6 weeks
Secondary outcome [5] 301869 0
Quality of recovery - assessed using two orthopaedic scores (Oxford hip/knee score) a validated quality of recovery tool (QoR-15) and a quality of life tool (EQ-5D)
Timepoint [5] 301869 0
Day 3 and 6 weeks
Secondary outcome [6] 301870 0
Persistent post-operative pain - assessed using the modified Brief Pain Inventory and the Neuropathic Pain Questionnaire.
Timepoint [6] 301870 0
3 months
Secondary outcome [7] 301871 0
Change in orthopaedic scores - Oxford hip and knee, WOMAC
Timepoint [7] 301871 0
6 weeks, 1 year

Eligibility
Key inclusion criteria
>45 years of age
Undergoing primary or revision total knee or hip replacement
At least one night inpatient stay

Minimum age
45 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Poor English language comprehension
Inability to obtain informed consent
Active thrombo-embolic disease such as DVT, PE, or cerebral thrombosis
History of postoperative or spontaneous DVT, pulmonary embolism, spontaneous arterial thrombosis or familial hypercoagulability
End-stage renal failure
Recent haematuria
Contraindication or allergy to TXA
Patients who have received TXA or DDAVP in the last 7 days
Pregnancy
Oral contraceptive (other than low dose Progesterone only)

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)
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
Phase 4
Type of endpoint(s)
Safety
Statistical methods / analysis

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,VIC
Recruitment hospital [1] 784 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 9438 0
Calvary Wakefield Hospital - Adelaide
Recruitment hospital [3] 9439 0
The Alfred - Prahran
Recruitment postcode(s) [1] 18150 0
3004 - Prahran

Funding & Sponsors
Funding source category [1] 286925 0
Other
Name [1] 286925 0
Australian and New Zealand College of Anaesthetists
Address [1] 286925 0
ANZCA House
630 St Kilda Road
Melbourne Vic 3004
Country [1] 286925 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Terrace
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 285713 0
Other
Name [1] 285713 0
Australian and New Zealand College of Anaesthetists
Address [1] 285713 0
ANZCA House
630 St Kilda Road
Melbourne Vic 3004
Country [1] 285713 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288982 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 288982 0
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Ethics committee country [1] 288982 0
Australia
Date submitted for ethics approval [1] 288982 0
24/04/2013
Approval date [1] 288982 0
06/05/2013
Ethics approval number [1] 288982 0
HREC/13/RAH/89
Ethics committee name [2] 299089 0
Alfred Hospital Ethics Committee
Ethics committee address [2] 299089 0
Ethics committee country [2] 299089 0
Australia
Date submitted for ethics approval [2] 299089 0
24/07/2014
Approval date [2] 299089 0
10/12/2014
Ethics approval number [2] 299089 0
242/14
Ethics committee name [3] 299090 0
Calvary Health Care Adelaide Human Research Ehtics Committee
Ethics committee address [3] 299090 0
89 Strangways Terrace
North Adelaide
SA 5006
SA
Ethics committee country [3] 299090 0
Australia
Date submitted for ethics approval [3] 299090 0
23/11/2013
Approval date [3] 299090 0
30/01/2014
Ethics approval number [3] 299090 0
13-CHREC-F007

Summary
Brief summary
The aim of this pilot trial is to evaluate the feasibility of conducting a large multi-centre trial which will investigate the efficacy and safety of tranexamic acid in patients undergoing lower-limb arthroplasty.

Tranexamic acid has been approved for use in lower limb arthroplasty in Australia. Although there is evidence to support its efficacy in reducing bleeding, trials examining the incidence of uncommon but serious thrombotic complications in patients receiving TXA for arthroplasty procedures have been small and heterogeneous. A large randomised controlled trial is required, and this pilot study is designed to enable the refining of trial methodology and to determine the feasibility of conducting trial procedures in a smaller group.
Trial website
Trial related presentations / publications
Preliminary results of the TALLAS trial to 6 months were presented by Dr Painter to the 2017 ANZCA ASM, "Breaking Trials' session in May 2017.
Public notes

Contacts
Principal investigator
Name 38634 0
Dr Tom Painter
Address 38634 0
Department of Anaesthesia
Royal Adelaide Hospital
Port Road
Adelaide
SA 5000
Country 38634 0
Australia
Phone 38634 0
+ 61 8 7074 1250
Fax 38634 0
Email 38634 0
thomas.painter@sa.gov.au
Contact person for public queries
Name 38635 0
Dr Tom Painter
Address 38635 0
Department of Anaesthesia
Royal Adelaide Hospital
Port Road
Adelaide
SA 5000
Country 38635 0
Australia
Phone 38635 0
+ 61 8 7074 1250
Fax 38635 0
Email 38635 0
thomas.painter@sa.gov.au
Contact person for scientific queries
Name 38636 0
Dr Tom Painter
Address 38636 0
Department of Anaesthesia
Royal Adelaide Hospital
Port Road
Adelaide
SA 5000
Country 38636 0
Australia
Phone 38636 0
+ 61 8 7074 1250
Fax 38636 0
Email 38636 0
thomas.painter@sa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary